Colic & Fussiness
Synopsis
Colic & Fussiness in Infancy: A Nutritional and Natural-Health Reference
1. Definition and Classification
Infantile colic is a functional gastrointestinal disorder (FGID) of early infancy defined by recurring bouts of unexplained, paroxysmal crying and fussiness in an otherwise healthy, well-nourished infant. Persistent and inconsolable crying episodes in an otherwise healthy and well-fed infant characterize infantile colic. Because no structural or biochemical abnormality underlies the condition, it is classified among the FGIDs — gastrointestinal tract issues that lack clear structural or biochemical causes.
The earliest widely adopted diagnostic benchmark was proposed in 1954. In 1954, Wessel et al. published an article titled "Paroxysmal Fussing in Infancy, Sometimes Called Colic," describing infantile colic. Wessel proposed a diagnostic criterion known as the "Rule of 3," which remains helpful today: infants affected by colic experience bouts of fussiness and crying that last at least 3 hours a day for 3 or more days a week for over 3 weeks.
In 2016, the Rome Foundation issued updated diagnostic criteria — the Rome IV criteria — which substantially revised the Wessel benchmark. A major revision was made for the criteria of infant colic in Rome IV; the modified Wessel's criteria used in Rome III were abandoned. The modified Wessel's criteria required the crying to occur for more than 3 hours per day, on at least 3 days per week. The Rome IV guidelines include the following: an infant younger than five months of age when the symptoms start and stop; recurrent and prolonged periods of infant crying, fussing, or irritability without apparent cause that cannot be prevented or resolved by caregivers; and no evidence of poor weight gain, fever, or illness. Three weeks was considered arbitrary, and it was judged unreasonable to require worried parents or caregivers to wait that long before intervening.
2. Presentation and Natural Course
Infants typically experience abdominal discomfort as a manifestation of infantile colic, which is a benign condition occurring in the second or third week of their lives. The condition typically presents in the second or third week, peaks around six weeks, and resolves by 12 weeks in 60% of infants and by 16 weeks in 90%. Colic is commonly described as a behavioral syndrome in neonates and infants characterized by excessive, paroxysmal crying. It is most likely to occur in the evenings, and it occurs without any identifiable cause.
The clinical picture has recognizable physical features. Inconsolable crying, irritability, and screaming without an apparent cause characterize colic. During these episodes, which often occur in the evening, affected infants typically appear red-faced, draw up their legs, and tense their abdomens. Traditional methods of soothing usually fail to relieve the infant's fussiness. As described in one PMC source, the condition is characterized by inconsolable crying and screaming for no apparent reason; the child has a tense stomach, tightened legs, and a red face.
Colic is among the most common reasons families seek early pediatric care. This condition distresses and challenges caregivers, leading to 10% to 20% of pediatric provider visits during the first few weeks of life. A systematic review by Wolke et al. using diary data from 8,690 infants showed that colic resolves spontaneously over time. They found that almost 25% of normal infants experience colic at 6 weeks of age compared to only 0.6% at 10–12 weeks. Using the Rome IV criteria, among infants aged 0–6 months, the reported prevalence of colic ranged between 10–15%.
3. Body Systems Involved
Infantile colic engages multiple overlapping physiological systems. Pathophysiological hypotheses include psychosocial stress, neurodevelopmental immaturity, immature gastrointestinal motility, and gut dysbiosis. The interactions among these systems are complex and incompletely understood.
3a. Gastrointestinal System
The gastrointestinal tract is the system most directly associated with colic symptomatology. Factors influencing the microbiome can cause dysbiosis and precipitate symptoms of colic through several mechanisms such as increased gas production and low-grade gut inflammation. Gut inflammation, as measured by fecal calprotectin, and alterations in the fecal microbiome may also contribute to infantile colic. Bile acid metabolism has also been implicated: when exploring the causes of colic, researchers have considered the possibility that immaturity in hepatic synthesis, reduced levels of intraluminal bile acids, and impaired ileal bile absorption of bile acids result in malabsorption of fat and other nutrients.
3b. Neuroendocrine and Hormonal System
Several gut hormones appear to behave atypically in colicky infants. Some studies support the presence of increased motilin in newborns and infants with colic, suggesting gut hypermotility as a result of autonomic imbalance. Gut hormones such as motilin may play a causative role in colic. Motilin is thought to cause hyperperistalsis, leading to abdominal pain and colic.
A complementary hypothesis involves the serotonin–melatonin axis. It is hypothesized that in the evening, peak serotonin concentration causes intestinal cramps associated with colic because serotonin increases intestinal smooth muscle contractions. Melatonin has the opposite effect of relaxing intestinal smooth muscles. Both serotonin and melatonin exhibit a circadian rhythm with peak concentrations in the evening. However, serotonin intestinal contractions are unopposed by melatonin during the first 3 months because only serotonin circadian rhythms are present at birth. Melatonin circadian rhythms appear at 3 months of age. The cramps of colic disappear at 3 months of age. This is a hypothesis derived from mechanistic and correlational data, not yet confirmed by large interventional trials.
3c. Gut Microbiome
Despite methodological limitations, data show alterations in microbial diversity, stability, and colonisation patterns in colicky infants compared to healthy controls. Infants with colic have been found to have higher levels of opportunistic bacteria such as Clostridium, Escherichia coli, and Enterobacteriaceae. These bacteria have been associated with gut inflammation, diarrhea, and other digestive issues. Colic is linked with gut inflammation (as determined by fecal calprotectin) and dysbiosis, independent of mode of feeding, with fewer Bifidobacteria.
Imbalances in lactate, H₂, and H₂S metabolism may induce flatulence and bloating and associated pain in colic infants. Several studies have identified higher breath H₂ excretion in colic infants compared to healthy controls, and positively correlated breath H₂ with crying time.
3d. Psychosocial and Nervous System
Other proposed contributing factors include maternal smoking or nicotine replacement therapy, the immaturity of the nervous and gastrointestinal systems, sleep disruption, hypersensitivity to the environment, sensory overload, family stress, gastroesophageal reflux, and parental anxiety. Maternal mental health has repeatedly been associated with infant colic, likely representing a multifaceted bidirectional relationship.
3e. Neurological Links
Certain studies have suggested a link between colic and migraine, demonstrating an association between infantile colic and the later development of migraine headaches during adolescence.
4. Contributing and Associated Factors
4a. Microbiome Dysbiosis
In infantile colic, when the microbial structure was evaluated, it was seen to be characterized by different microbial patterns. In the first 2 weeks of life, infants with infantile colic have been reported to have a lower variety and stability of the gut microbiota. In colic babies, E. coli bacteria are found to be excessive, and the amounts of Bifidobacterium and Lactobacilli are decreased. Coliforms are reported to cause pain by creating excessive gas and inflammatory lipopolysaccharides as a result of intestinal fermentation.
Other possible microbiome-disrupting factors include immaturity of the enterohepatic bile acid cycle and administration of antibiotics and other medications during the perinatal period. Preterm delivery and neonatal use of antibiotics in the first months of life are associated with an increased incidence of FGIDs, particularly infantile colic and regurgitation.
4b. Feeding Mode
Breastfeeding duration has been associated with colic risk, but quite inconsistently across studies, leaving breastmilk's role in colic unclear. Breastfeeding appears to support healthy stool consistency and frequency during infancy, with some speculation that human milk oligosaccharides (HMOs) in breastmilk mediate some part of these benefits. HMOs are a diverse collection of non-digestible carbohydrates that can beneficially influence microbiota development in breastfed infants.
4c. Maternal Smoking
Exposure to cigarette smoke may be related to colic; this might be connected to an increase of plasma and intestinal levels of motilin. Maternal smoking during pregnancy seems to increase the risk of developing colic more than postnatal exposure to smoke.
4d. Psychosocial Environment
Infantile colic may be more frequent in an unstable psychosocial family environment. Maternal stress, anxiety, and depression are important risk factors.
4e. Mode of Delivery
Cesarean delivery and feeding pattern at 1 month of life emerged as additional risk factors for infant dyschezia and functional diarrhea, and are discussed in broader FGID literature as factors that may alter early microbiome colonization patterns relevant to colic.
5. Nutrients, Herbs, and Natural Ingredients
5a. Probiotics
Traditional Use
The targeted use of specific probiotic strains for infant colic is a modern clinical practice rather than a classical herbal or folk tradition. Fermented dairy products have been part of many traditional diets globally for centuries, but the application of defined probiotic strains at specified colony-forming unit doses to treat infant colic is a product of late-20th and early-21st century nutritional science.
Scientific Evidence: Lactobacillus reuteri
Lactobacillus reuteri, particularly the strains ATCC 55730 and DSM 17938, is the most studied probiotic in the context of infantile colic and carries the strongest evidence base. Six randomized controlled trials of 423 infants with colic were included in one meta-analysis, with 213 in the L. reuteri group and 210 in the placebo group. Lactobacillus reuteri increased colic treatment effectiveness at two weeks (RR = 2.84; 95% CI: 1.24–6.50; p = 0.014) and three weeks (RR = 2.33; 95% CI: 1.38–3.93; p = 0.002), but not at four weeks (RR = 1.41; 95% CI: 0.52–3.82; p = 0.498).
One network meta-analysis examined multiple therapeutic approaches simultaneously. Daily crying times fell to 35.0 (IQR 85) vs 90.0 (IQR 148) minutes per day at day 21 (P = .022) with no differences in weight gain, stooling frequency, or incidence of constipation or regurgitation between groups, and no adverse events related to supplementation were observed in one RCT. Three years later, a second similarly designed RCT in 80 infants aged <5 months identified that the rate of responders to treatment was significantly higher in the probiotic group compared with the placebo group at day 7 (P = .026), at day 14 (RR 4.3, 95% CI 2.3–8.7), at day 21 (RR 2.7, 95% CI 1.85–4.1), and at day 28 (RR 2.5, 95% CI 1.8–3.75).
A 2019 systematic review with meta-analysis confirmed a preventive benefit: one double-masked, placebo-controlled randomized clinical trial investigated whether oral supplementation with Lactobacillus reuteri DSM 17938 during the first 3 months of life could reduce the onset of colic, gastroesophageal reflux, and constipation in term newborns. Prophylactic use of L. reuteri DSM 17938 during the first 3 months of life reduced the onset of functional gastrointestinal disorders.
A noteworthy limitation of the probiotic evidence is that most positive trials were conducted in breastfed infants. The probiotic Lactobacillus reuteri DSM 17938 was shown to be effective in breastfed infants with colic; results in exclusively formula-fed infants are less consistent. In included meta-analyses, Lactobacillus reuteri (strains ATCC 55730 and DSM 17938) was the only species utilized in the therapeutic intervention, and two of the trials were industry funded. This potential for industry bias and the restriction to breastfed cohorts are widely acknowledged limitations. The overall evidence strength for L. reuteri in breastfed infants is moderate, based on multiple small-to-medium RCTs; evidence in formula-fed infants remains weak.
One RCT also investigated maternal probiotic supplementation. Recent studies have suggested that dysbiosis may play a role in the pathogenesis of infantile colic and that modulating the gut microbiota, including the use of probiotics, may aid its management. One single-blind randomized controlled study evaluated the effect of probiotics added to the diet of mothers on infantile colic symptoms and neonatal gut microbiota content. The study found changes in microbiota beta-diversity; however, this remains a preliminary finding requiring replication.
5b. Fennel (Foeniculum vulgare)
Traditional Use
Fennel (Foeniculum vulgare), a culinary and folk medicinal plant used worldwide in infantile colic, bloating, and indigestion, has scarce scientific evidence. Fennel seed preparations — including teas, distillates, and seed oil emulsions — have been used across Mediterranean, Middle Eastern, South Asian, and Central European traditional medicine for gastrointestinal complaints including infantile colic and flatulence. According to classical texts and pharmacological references, herbal distillates derived from plants such as fennel, thyme, green cumin, ajwain, chamomile, licorice, coriander, lemon balm, anise, celery, savory, dill, ginger, and peppermint are widely used to alleviate infantile colic.
Scientific Evidence
Fennel seed oil has been shown to reduce intestinal spasms and increase motility of the small intestine. In clinical trial settings, in a double-blind, randomized, placebo-controlled trial, fennel oil treatment eliminated infantile colic in 65% of patients, compared to 23.7% in the placebo group. Arikan et al. reported a significant effect of fennel tea on daily crying time in infants (P < .001) after administration for 1 week.
A narrative review of nutraceuticals and gut-brain disorders found that significant reductions in colic episodes and crying time were reported in two studies on fennel (seed oil or tea), in three studies on different multiple herbal extracts (all including fennel), in one study on Mentha piperita, and in at least two double-blind randomized controlled studies on Lactobacillus reuteri DSM 17938 and Bifidobacterium lactis BB-12 in breastfed infants.
A systematic review of interventions for breastfed infants concluded that probiotics, in particular L. reuteri, and preparations containing fennel oil appear effective for reducing colic, although there are limitations to these findings. Evidence for fennel is graded as preliminary-to-moderate: positive RCTs exist but trial sizes are small and methodology varies.
5c. Chamomile (Matricaria chamomilla)
Traditional Use
Chamomile has been used in European and Middle Eastern folk medicine for centuries as an antispasmodic and carminative for gastrointestinal complaints in all age groups, including infants. Compounds such as flavonoids in chamomile and anethole in fennel exhibit properties such as analgesic and anti-inflammatory effects that may alleviate colic symptoms.
Scientific Evidence
A double-blind, randomized, placebo-controlled trial examined a standardized extract combining chamomile (Matricaria recutita), fennel (Foeniculum vulgare), and lemon balm (Melissa officinalis): one study of 93 infants found that average daily crying time in breastfed babies reduced within one week of treatment with a fennel, chamomile, and lemon balm extract, with no adverse effects. A proprietary formula containing chamomile, fennel, and lemon balm demonstrated statistically better results in daily crying time and percentage of responders compared to the control group.
A multi-herb herbal tea has also been studied: another study observed that herbal tea containing fennel, chamomile, liquorice, vervain, and lemon balm effectively reduced colic in 57% of infants compared to placebo (26%) (P < .01). The individual contribution of chamomile within these combination preparations cannot be isolated from these trials.
5d. Peppermint (Mentha piperita)
Traditional Use
Peppermint has a long history of use in European and Asian traditional medicine as a carminative for digestive complaints including flatulence and abdominal cramping in adults; its application to infant colic is an extension of this tradition found in some folk practices.
Scientific Evidence
A double-blind crossover study on 30 infants with colic showed a promising effect of peppermint in relieving colic symptoms compared to simethicone. This finding is preliminary; large confirmatory trials are lacking.
5e. Lemon Balm (Melissa officinalis)
Traditional Use
Lemon balm has been used in European herbal medicine since antiquity as a sedative and antispasmodic for gastrointestinal and nervous system complaints. Its use in infant colic preparation is documented in traditional Iranian, German, and broader European herbal practice, typically as a tea or distillate.
Scientific Evidence
As noted above, lemon balm has been studied as part of multi-herb formulations (with fennel and chamomile) rather than as a standalone intervention in infant colic. The available RCT data support the combination products, but do not allow attribution of effect to lemon balm alone. Evidence is preliminary and indirect.
5f. Other Traditionally Used Herbs
In addition to the above, herbal distillates derived from plants including thyme, green cumin, ajwain, licorice, coriander, anise, celery, savory, dill, and ginger are widely used in traditional medicine — particularly in Iranian traditional medicine — to alleviate infantile colic. For most of these herbs individually, rigorous clinical trial evidence in infants is absent or limited to small observational studies.
5g. Simethicone
Simethicone (a silicone-based anti-foaming agent) is widely used by parents for infant gas and colic. Its mechanism involves reducing surface tension of gas bubbles, theoretically easing their passage. However, the clinical evidence does not support its superiority over placebo. The evidence for maternal dietary manipulation, lactase, sucrose, glucose, and simethicone is weak. Pharmacological studies on simethicone gave conflicting results. Simethicone is considered to have a weak and inconsistent evidence base for infant colic.
5h. Lactase
The hypothesis that lactose intolerance or relative lactase deficiency contributes to colic in some infants has driven interest in exogenous lactase supplementation. The connection to lactose intolerance presents more contradictory evidence. Systematic reviews have not found consistent benefit from lactase supplementation in unselected colicky infants, and the evidence for lactase is weak.
6. Dietary Factors
6a. Maternal Diet in Breastfeeding: Cow's Milk Protein Elimination
The potential role of allergens transferred through breast milk — especially cow's milk proteins — has been investigated for decades. There is some experimental evidence on the association between maternal intake of cow's milk and crying in colicky infants, and several studies have demonstrated a reduction in colic when breastfeeding mothers consumed a hypoallergenic diet.
Early studies suggested meaningful benefit. Jakobsson and Lindberg reported that the removal of cow's milk from the breastfeeding mother's diet resulted in the disappearance of colic in 13 of 18 infants. However, this was not a double-blind study and involved a small sample size. A larger follow-up study found that the same authors put 66 mothers of breastfed infants with infantile colic on a diet free of cow's milk; the colic disappeared in 35 infants, but it reappeared on at least two challenges after reintroduction of cow's milk into the maternal diet in 23 of the 35 infants, and there was a family history of allergy in 12 of the infants.
The quality of this evidence base has been critically assessed. A 2018 Cochrane Database systematic review of dietary interventions for treating infant colic highlighted the limitations of earlier studies and concluded "evidence of the effectiveness of dietary modifications for the treatment of infantile colic is sparse and at significant risk of bias." A 2020 EAACI position paper could only make grade C or D level evidence-based recommendations regarding the use of maternal cow's milk elimination diets for managing gastrointestinal symptoms associated with presumed non–IgE-mediated cow's milk allergy in breastfed infants.
In breastfed infants, evidence suggests that a hypoallergenic maternal diet may be beneficial for reducing symptoms of colic. Evidence suggests that eliminating certain allergenic foods (e.g., cow's milk, eggs, fish, peanuts, soy, tree nuts, wheat) from breastfeeding mothers' diets may reduce colic symptoms. However, in breastfed babies, efforts to identify potential offending foods in the maternal diet have yielded inconsistent results. Current evidence is rated at a low-to-moderate level overall.
6b. Maternal Low-FODMAP Diet
A notable randomized double-blind crossover feeding study examined the effect of a maternal low-FODMAP (Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols) diet in breastfeeding mothers of colicky infants. The study examined effects of a maternal low-FODMAP diet compared to a typical-Australian diet on infant crying-fussing durations. Exclusively breastfed infants aged ≤9 weeks meeting Wessel criteria for colic were recruited between 2014 and 2016. Mothers were provided a 10-day low-FODMAP or typical-Australian diet, then alternated without washout. Crying-fussing durations fell by a median of 32% during the low-FODMAP diet compared with 20% during the typical-Australian diet (P = 0.03). In breast milk, lactose concentrations remained stable and other known dietary FODMAPs were not detected. Maternal low-FODMAP diet was associated with enhanced reduction in crying-fussing durations of infants with colic. This was not related to changes in maternal psychological status, gross changes in breast milk, or infant faeces. This trial was small (13 colicky infants) and its results should be regarded as preliminary.
6c. Formula Modifications in Formula-Fed Infants
For formula-fed infants, dietary modifications have been studied with somewhat stronger evidence. In formula-fed infants, colic may improve after changing from a standard cow's milk formula to either a hydrolysed protein formula or a soy-based formula. Fibre-supplemented formulae had no effect.
The Cochrane review found: partially hydrolysed, lower-lactose, whey-based formulae containing oligosaccharide versus standard formula with simethicone showed both groups experienced decreased colic episodes after seven days; this difference was significant after two weeks, and the study author confirmed there were no adverse effects. There is some scientific evidence to support the use of a casein hydrolysate formula in formula-fed infants or a low-allergen maternal diet in breastfed infants with infantile colic.
6d. Maternal Cruciferous Vegetables and "Windy Foods"
A significantly higher risk of colic symptoms versus control (relative risk 1.6, 95% CI 1.1 to 1.4) was noted with maternal intake of cruciferous vegetables. The folk advice to avoid "windy" or gas-producing foods while breastfeeding has some limited observational backing, though the mechanism and causal directionality of such associations are not established.
7. Lifestyle and Psychosocial Factors
Beyond diet and nutrients, several lifestyle factors are discussed in the peer-reviewed literature in relation to infant colic and fussiness:
- Maternal mental health: Maternal mental health has repeatedly been associated with infant colic, likely representing a multifaceted bidirectional relationship. Microbiome-focused research projects should not ignore the contextual relevance of maternal mental health, infant nutrition choices and timelines, and other relevant biopsychosocial factors.
- Tobacco exposure: The exposure to cigarette smoke may be related to colic; this might be connected to the increase of plasma and intestinal levels of motilin. Maternal smoking during pregnancy seems to increase the risk of developing colic more than postnatal exposure to smoke.
- Mode of delivery: Cesarean section is associated with altered early microbiome colonization and has been discussed as a potential risk factor for FGIDs including colic, consistent with the dysbiosis hypothesis.
- Antibiotic exposure: Preterm delivery and neonatal use of antibiotics in the first months of life are associated with an increased incidence of FGIDs, particularly infantile colic and regurgitation.
8. Evidence Summary and Strength of Findings
Owing to a lack of large, high-quality randomized controlled trials, none of the currently proposed therapies for infant colic are strongly recommended. The table below summarizes evidence quality for the main nutritional and natural interventions discussed in the literature:
- Lactobacillus reuteri DSM 17938 (oral, infant or maternal): The strongest evidence base among natural/nutritional interventions. Multiple RCTs and meta-analyses support efficacy in breastfed infants at 2–3 weeks. Industry funding of some trials and restriction to breastfed cohorts are acknowledged limitations. Evidence is rated moderate.
- Fennel seed oil / fennel tea: Positive results from small RCTs and combination-herb trials. Mechanism (antispasmodic via anethole) is plausible. Evidence is preliminary to moderate.
- Chamomile/fennel/lemon balm combination extracts: Supported by at least one RCT of 93 breastfed infants. Evidence for individual herbs within combinations cannot be isolated. Rated preliminary.
- Hydrolysed cow's milk formula (formula-fed infants): Some evidence of benefit; rated low to moderate, with methodological limitations.
- Hypoallergenic/low-allergen maternal diet: Evidence exists but is sparse and at significant risk of bias per the 2018 Cochrane review. Rated low.
- Maternal low-FODMAP diet: One small positive RCT (n=13 colicky infants). Very preliminary; rated insufficient for conclusions.
- Simethicone: Conflicting results across RCTs; no clear benefit over placebo. Rated weak/insufficient.
- Lactase supplementation: Weak and inconsistent evidence; rated weak.
- Peppermint: One small crossover study; very preliminary evidence.
References
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- Daeppen LI & Tremblay M. (Updated 2023). Infantile Colic. StatPearls. NCBI Bookshelf.
- Infantile Colic (Nursing). StatPearls. NCBI Bookshelf.
- Zeevenhooven J, Koppen IJ, Benninga MA. (2017). The New Rome IV Criteria for Functional Gastrointestinal Disorders in Infants and Toddlers. Pediatric Gastroenterology, Hepatology & Nutrition. PMC.
- Hyams JS, et al. (2022). A Narrative Review on the Update in the Prevalence of Infantile Colic, Regurgitation, and Constipation in Young Children: Implications of the ROME IV Criteria. PMC.
- Faecal Microbiota in Infants and Young Children with Functional Gastrointestinal Disorders: A Systematic Review. PMC.
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- Compositional and functional variability of the gut microbiome in children with infantile colic. PMC / Scientific Reports.
- The influence of the gastrointestinal microbiome on infant colic. PubMed.
- Rhoads JM, et al. (2018). Infant Colic Represents Gut Inflammation and Dysbiosis. Journal of Pediatrics. ScienceDirect.
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Natural Remedies
Ingredients
- 2'-fucosyllactoseScientific
2'-Fucosyllactose (2'-FL) is the most abundant human milk oligosaccharide and has been clinically studied in infant formula to reduce fussiness and colic symptoms. In one clinical study, 63.8% of infants switched to a formula containing 2'-FL showed improvement in fussiness after just one day. A 2024 prospective clinical trial found formula supplemented with 2'-FL reduced infantile colic incidence versus unsupplemented formula.
- bifidobacterium animalisScientific
B. animalis subsp. lactis BB-12 has been evaluated in randomized controlled trials for infant colic, with positive results. A published RCT found BB-12 supplementation reduced mean daily crying episodes significantly more than placebo, with an increase in Bifidobacterium abundance correlating with crying time reduction. Gut dysbiosis has been implicated in infantile colic, and BB-12 is included among well-studied probiotic strains for this condition.
- bifidobacterium breveScientific
Bifidobacterium breve has been evaluated in dedicated RCTs for infantile colic. The strain B. breve CECT7263, isolated from breastmilk, was found in a randomized controlled trial to be more effective than simethicone for infantile colic treatment. B. breve is also included in multi-strain probiotic combinations showing colic benefit.
- bifidobacterium infantisScientific
Bifidobacterium infantis (B. longum subsp. infantis) has been studied for infantile colic due to its key role in establishing healthy gut microbiota in breastfed infants. Infants with colic show reduced Bifidobacteria, and B. infantis supplementation is studied as a corrective probiotic intervention. Multi-strain probiotic preparations containing B. infantis have demonstrated reductions in colic crying duration.
- bifidobacterium lactisScientific
Bifidobacterium lactis BB-12 (Bifidobacterium animalis subsp. lactis) has been evaluated in dedicated double-blind RCTs for infantile colic with positive results. An 80-infant RCT found that B. lactis BB-12 at 10^9 CFU/day significantly reduced daily crying duration versus placebo starting from the second week. It is also incorporated in 2'-FL-supplemented formula studies for fussiness.
- bifidobacterium longumScientific
B. longum (particularly subspecies infantis) has been studied as an intervention for infant colic and functional gastrointestinal disorders. Observational pilot trial data show that B. longum KABP042 combined with Pediococcus pentosaceus KABP041 shows potential to treat pediatric functional gastrointestinal disorders including infant colic. B. infantis is well adapted to the infant gut and supports gut homeostasis relevant to colic.
- carawayScientific
Caraway (Carum carvi) is documented in traditional medicine as a carminative and has been included in combination products tested in clinical trials for infantile colic. The 2022 Evans and Lorentz open-label trial included caraway as part of a multi-herb colic relief preparation showing significant reductions in crying time. Traditional scholars in Iranian and European medicine widely used caraway as a leading anti-colic, carminative herb.
- chamomileScientific
Chamomile (Matricaria recutita/chamomilla) has been tested in multiple RCTs for infantile colic, both as a single agent and in multi-herb preparations. A herbal tea containing chamomile reduced colic in 57% of infants versus 26% with placebo in one RCT. Topical chamomile oil also showed significant reductions in crying and fussing in breastfed colicky infants.
- fennelScientific
Fennel seed oil and fennel-based preparations have been tested in multiple randomized controlled trials for infantile colic. A fennel seed oil emulsion alleviated colic in 65% of enrolled infants versus placebo in one RCT. Systematic review and meta-analysis confirm fennel alone or in combination is effective at reducing colic symptoms.
- FOS (fructooligosaccharides)Scientific
Fructooligosaccharides (FOS) have been used as a prebiotic synbiotic partner in multi-strain probiotic preparations studied for infantile colic. One cited RCT using a combination of seven probiotic strains plus FOS reduced daily crying duration by approximately 35 minutes versus placebo. FOS selectively stimulate Bifidobacteria, which are deficient in colicky infants.
- gingerScientific
Ginger (Zingiber officinale) is included in multi-herb colic relief preparations that have shown clinical benefit in open-label and controlled trials. It contributes carminative and antispasmodic effects to combination products such as gripe water formulas tested for infantile colic. Traditional use of ginger for infant colic is widespread across multiple cultures.
- lactaseScientific
Transient lactase deficiency in infants has been proposed as a contributing factor to colic, with undigested lactose fermenting in the colon to produce gas and discomfort. Multiple RCTs have tested oral lactase supplementation in colicky infants with mixed results. A 2024 systematic review of six RCTs (n=394 infants) found that three studies reported shorter crying time with lactase, while three found no significant difference, leaving overall evidence inconclusive.
- lactobacillus acidophilusScientific
Lactobacillus acidophilus has been studied as part of multi-strain probiotic combinations for infantile colic, including in combination with chamomile and lemon balm. An open RCT found a preparation combining M. chamomilla, M. officinalis, and tyndallized L. acidophilus HA122 was significantly more effective than simethicone in reducing colic crying time. It also appears in multi-strain preparations studied for colic prevention.
- lactobacillus bulgaricusScientific
Lactobacillus bulgaricus (Lactobacillus delbrueckii subsp. bulgaricus) has been included in multi-strain probiotic combinations shown to reduce daily crying duration in infants with colic. The combination containing L. bulgaricus along with multiple other strains and FOS reduced crying by approximately 35 minutes versus placebo in a cited clinical trial.
- lactobacillus reuteriScientific
Lactobacillus reuteri DSM 17938 is the most extensively studied probiotic for infantile colic, with multiple RCTs and meta-analyses confirming efficacy in breastfed infants. A 2018 meta-analysis in Pediatrics pooled data from multiple trials showing significant reduction in crying time. Its mechanism involves modulating gut microbiota and reducing intestinal inflammation.
- lactobacillus rhamnosusScientific
Lactobacillus rhamnosus has been included in multi-strain probiotic combinations studied for infantile colic, with one combination reducing daily crying duration by approximately 35 minutes versus placebo. It is a well-studied probiotic for pediatric gastrointestinal conditions. Evidence for colic is primarily as part of combination probiotic products.
- lemon balmScientific
Lemon balm has been tested in clinical trials in infants with colic, both as a mono-ingredient and in combination products. A 2005 double-blind RCT (ColiMil) found that an extract of Matricaria, fennel, and Melissa significantly reduced daily crying time in breastfed colicky infants versus placebo. A 2017 RCT confirmed efficacy of a multi-ingredient preparation containing Melissa. German Commission E and EMA recognise lemon balm for gastrointestinal spasm.
- peppermintScientific
Peppermint (Mentha piperita) has been shown in a double-blind crossover study to relieve colic symptoms in infants compared to simethicone. It is included in multi-herb colic preparations tested in clinical trials. The AAFP's clinical review cites peppermint as one of several herbal supplements that have reduced crying time in colic studies.
- streptococcus thermophilusScientific
Streptococcus thermophilus has been evaluated in combination probiotic products for infantile colic, including a product with B. animalis subsp. lactis BB-12 that reduced caregiver-reported colic incidence. It is part of a multi-strain combination that reduced crying duration by approximately 35 minutes versus placebo. Evidence is from combination probiotic studies rather than standalone trials.
- ajwainTraditional
Ajwain water is among the most commonly used traditional remedies for infant colic across South Asia and the Middle East. Its antispasmodic and carminative properties are attributed to thymol. Mechanistic preclinical data support smooth muscle relaxation; pediatric RCT evidence is absent.
- aniseTraditional
Anise (Pimpinella anisum) is widely used traditionally in European, Middle Eastern, and Iranian medicine for infant colic as a carminative and antispasmodic herb. Anise is cited in traditional herbal medicine reviews and pharmacopeias as a carminative remedy for colic and flatulence. Clinical trial evidence for anise alone in infant colic is limited, making its status primarily traditional.
- corianderTraditional
Coriander (Coriandrum sativum) is documented in traditional Iranian, European, and Ayurvedic medicine as a carminative herb used to relieve infant colic and flatulence. Herbal distillates of coriander are among the key traditional remedies for infantile colic in Iranian medical texts. No standalone clinical trial evidence for coriander in infant colic was identified.
- dillTraditional
Dill (Anethum graveolens) has centuries of traditional use as a carminative and anti-colic herb across European, Middle Eastern, and Iranian traditional medicine. Herbal distillates of dill are documented in traditional Iranian medicine for relieving infantile colic and bloating. Clinical trial evidence for dill alone in infant colic is absent, placing it in the traditional category.
- ferula assafoetidaTraditional
Asafoetida has been used in traditional medicine across the Middle East, South Asia, and North Africa as a remedy for infant colic and flatulent colic in adults. It was historically employed for infantile colic and pneumonia. Use in infants carries a documented safety risk (methemoglobinemia has been reported in neonates) and is not recommended clinically.
- slippery elm barkTraditional
Slippery elm bark has a documented traditional use for colic, cited in multiple herbal references and historically used as a soothing porridge for weaned infants. No controlled clinical trials have evaluated this application. The soothing demulcent effect on gastrointestinal mucosa provides the rationale.
- sweet flagTraditional
A. calamus rhizome has been used in Indian, South Asian, and African traditional medicine specifically for infant and childhood colic and related gastrointestinal distress. Antispasmodic activity in smooth muscle provides pharmacological plausibility. No clinical trials in infants have been identified.
- vervainTraditional
Vervain (Verbena officinalis) has traditional use for infantile colic as a component of multi-herb herbal teas. A 1993 double-blind RCT (Weizman et al., J Pediatr) tested a tea containing chamomile, vervain, licorice, fennel, and lemon balm that reduced colic in 57% of infants versus 26% with placebo. Vervain is listed by the AAFP as one of several herbs in preparations that have reduced infant crying time.