Lactobacillus rhamnosus

Lacticaseibacillus rhamnosus (Lactobacillus rhamnosus)

1. Identity

Nomenclature and Taxonomy

Lactobacillus rhamnosus (legacy name) is now formally reclassified as Lacticaseibacillus rhamnosus (current taxonomy); it was formerly also designated Lactobacillus casei subsp. rhamnosus, the species epithet rhamnosus referring etymologically to rhamnose. This taxonomic reclassification, placing the species into the genus Lacticaseibacillus, occurred in 2019–2020. Despite the updated nomenclature, the older name Lactobacillus rhamnosus remains in widespread use in the scientific literature, regulatory filings, and commercial products, and is used throughout this article for clarity and consistency.

Lactobacillus casei, Lactobacillus paracasei, and Lactobacillus rhamnosus are phenotypically and genotypically closely related and together comprise the L. casei group. Lactobacilli as a class are gram-positive, rod-shaped, facultatively anaerobic or microaerophilic, non-spore-forming, acid-tolerant, and catalase-negative bacteria with DNA G+C content usually less than 50 mol%. Members of the L. casei group are facultatively heterofermentative, have 45–47 mol% DNA G+C content, and share identical peptidoglycan types (L-Lys-D-Asp).

Lactobacillus rhamnosus is a facultative heterofermentative lactic acid bacterium (LAB) closely related to Lactobacillus casei and Lactobacillus zeae and encompasses a genetically diverse group of strains with a high frequency of discriminative core genome polymorphisms and a remarkable accessory genome, or variome distribution. This species has strain-specific genetic and metabolic characteristics that explain its occurrence in a variety of ecological niches.

Microbiological Characteristics

Lactobacillus rhamnosus is defined as a rod-shaped, gram-positive, aerophilic anaerobic bacterium that can colonize the human gastrointestinal and genito-urinary tracts, providing protective effects against infections such as urinary tract infections and bacterial vaginosis by producing organic acids and antimicrobial substances. It has 45–47% G+C content (mol%) and the lysine-d-aspartyl-type peptidoglycan; it grows at both 15 and 45 °C, produces the l-lactic acid isomer, and ferments carbohydrates such as arabinose, cellobiose, esculin, ribose, sorbitol, and sucrose.

The genome has been sequenced for the LGG strain (ATCC 53103), with a size of approximately 3.010 Mb.

Key Strains

The LGG strain (L. rhamnosus GG) was isolated and named after Gorbach and Goldin in the early 1980s and became a model probiotic strain widely studied in pediatric and adult clinical trials. The suffix "GG" denotes the two researchers' initials. Its ATCC designation is 53103. Lactobacillus rhamnosus GR-1 is a well-known probiotic strain isolated from a healthy female urethra and is the strain principally studied for urogenital applications. Different L. rhamnosus strains have distinct evidence bases: LGG for pediatric diarrhea and antibiotic-associated diarrhea (AAD); GR-1 for urogenital health.

Although the strains of this group are commercially valuable as probiotics, the taxonomic status and nomenclature of the L. casei group have long been contentious because of the difficulties in identifying these three species by using the most frequently used genotypic methodology of 16S rRNA gene sequencing. Currently, genome-based comparisons, including average nucleotide identity (ANI) and digital DNA–DNA hybridization (dDDH), are commonly applied to bacterial taxonomy as alternatives to the gold standard method for demarcating phylogenetic relationships.

Natural Sources

Natural sources include the human gastrointestinal tract, breast milk, fermented dairy products, and the urogenital tract (strain-dependent). Bacteriocinogenic L. rhamnosus strains have been isolated from human feces, vaginal microbiota, fermented beverages, grape peels, milk samples, and cheese. The origin of most of the Lactobacillus rhamnosus genome sequences lodged in NCBI can be traced to food and faecal isolates followed by blood and tissue sites, with minimal representation from oral and vaginal isolates.

Dosage Forms and Preparations

Manufacture involves industrial fermentation, concentration, cryoprotectants (e.g., trehalose, milk powder), lyophilization or spray drying, microencapsulation or enteric coating, and fill-finish into capsules, sachets, or food matrices. LGG is available in capsules, powders, and some dairy products. Widely known probiotic strains of this group are used worldwide in fermented dairy products or food supplements and as probiotics to enhance host health.

2. Historical and Traditional Use

Pre-Scientific Use via Fermented Foods

For thousands of years, fermented foods have been present in traditional diets around the world and continue to be widely consumed; historically, communities produced fermented foods within the home, a practice that continues to this day in many settings. Lactobacillus rhamnosus species has a long history of being used in fermentation, and it possesses a genome that allows it to adapt to a range of environments, including the human gastrointestinal and urogenital tracts.

It is important to note that there is no traditional medicinal use of a single bacterial species in the sense of herbal traditions; however, consumption of fermented dairy and fermented foods (which naturally contain lactic acid bacteria including L. rhamnosus-like organisms) has a long history for gastrointestinal health and food preservation. The species itself was only formally characterized in the 20th century. These are microbial species with a history of safe use, which again is due to their inclusion in a variety of foods.

L. rhamnosus has a long history in dairy fermentation and is commonly found in yogurt, where it is sometimes added alongside traditional starter cultures; beyond dairy, it has been successfully used to ferment millet, maize, and fruit juices. Alongside its use in health supplements, Lactobacillus species have been consumed for centuries through their use in the production of fermented foods such as yoghurt, kimchi, and kefir.

Modern Discovery and Development

The trajectory from traditional use to a defined supplement spans several decades: in the 1950s–1960s, early taxonomic recognition of Lactobacillus-like organisms occurred in dairy and human isolates; in the 1980s, the GG strain was isolated and described by Gorbach and Goldin; in the 1990s–2000s, clinical RCTs began to evaluate LGG for pediatric diarrhea and antibiotic-associated diarrhea; and in the 2000s–2010s, molecular characterization (SpaCBA pili, adhesins) and genome sequencing identified strain-specific features.

This history of safe use in a variety of foods, together with suitability for large-scale cultivation, may explain why Lactobacillus rhamnosus is the most studied Lactobacillus species for human application; the species can be recovered from some fermented foods and the intestinal and vaginal tracts, and strains appear to possess a number of interesting characteristics suitable for use in humans.

3. Key Constituents and Active Compounds

SpaCBA Pili

Lactobacillus rhamnosus GG, a probiotic with good survival capacity in the human gut, has well-documented adhesion properties and health effects; recently, spaCBA-encoded pili that bind to human intestinal mucus were identified on its cell surface. The SpaCBA pilus of L. rhamnosus GG is key for efficient adherence to the Caco-2 intestinal epithelial cell (IEC) line and biofilm formation. The long flexible pili of L. rhamnosus GG promote a strong interaction with substrates by a zipper-like mechanism involving SpaC adhesin subunits present at the tip but also along the pilus fibers.

Secreted Proteins: p40 and p75

p40 and p75 are major secreted proteins produced by Lacticaseibacillus rhamnosus GG (LGG), which is the best-studied probiotic bacterium. The genomes of L. casei/paracasei and L. rhamnosus strains carry two genes encoding homologues of p40 and p75 from L. rhamnosus GG, two secreted proteins which display anti-apoptotic and cell protective effects on human intestinal epithelial cells; p40 and p75 carry cysteine, histidine-dependent aminohydrolase/peptidase (CHAP) and NLPC/P60 domains, respectively, which are characteristic of proteins with cell-wall hydrolase activity.

Purified p40 and p75 stimulate Akt activation, display anti-apoptotic activity, prevent epithelial barrier damage caused by oxidative agents, and decrease susceptibility to dextran sodium sulfate-induced colon epithelial injury in mice. p40 promotes IgA production via upregulation of a proliferation-inducing ligand (APRIL) and stimulates mucin gene expression and production in LS174T cells and the mouse colonic epithelium. L. rhamnosus GG and L. casei BL23 purified P40 and P75 proteins have antiapoptotic activity by inducing the EGF/Akt pathway.

Exopolysaccharides (EPS)

Benefits of LGG have been linked to structural components or bioactive compounds; for example, immunomodulatory effects of the pili structure, stimulation of cell proliferation and protection from apoptosis induced by secreted proteins p40 and p75, and improved stress adaptability in the host by LGG exopolysaccharides. The spaCBA mutant without exopolysaccharides induces an elevated level of interleukin-8 (IL-8) mRNA in Caco-2 cells compared to the wild type, possibly involving an interaction of lipoteichoic acid with Toll-like receptor 2; in contrast, an L. rhamnosus GG mutant without exopolysaccharides but with increased exposure of pili leads to reduced expression of IL-8. This suggests that EPS modulates pilus-mediated immune signaling.

Lactic Acid and Bacteriocins

Lactobacillus rhamnosus provides protective effects against infections by producing organic acids and antimicrobial substances. It produces the l-lactic acid isomer and ferments carbohydrates such as arabinose, cellobiose, esculin, ribose, sorbitol, and sucrose. Some strains also produce bacteriocins; bacteriocinogenic L. rhamnosus strains have been isolated from a range of ecological niches including human feces, vaginal microbiota, fermented beverages, grape peels, milk samples, and cheese.

4. Mechanisms of Action

Intestinal Epithelial Adhesion and Barrier Enhancement

Probiotic mechanisms of L. rhamnosus GG include: (i) inhibition of pathogens, (ii) improvement of the epithelial barrier function, and (iii) modulation of host immune responses. LGG is resistant to acid and bile, adheres well to the human intestinal epithelium, and produces factors with activity against many bacterial species; studies suggest that LGG is important in promoting gut immune development, protection against inflammation-induced damage, and stimulating gut barrier function.

Immunomodulation

SpaCBA pili play a significant role in the capacity for adhesion to macrophages and also promote bacterial uptake by these phagocytic cells; these pili also mediate anti-inflammatory effects by induction of interleukin-10 (IL-10) mRNA and reduction of interleukin-6 (IL-6) mRNA in a murine RAW 264.7 macrophage cell line, appearing to mediate these effects indirectly by promoting close contact with macrophages, facilitating the exertion of anti-inflammatory effects by other surface molecules via yet unknown mechanisms.

Probiotic bacteria have been shown to induce IL-10 producing regulatory T cells through dendritic cell-specific intercellular adhesion molecule-3-grabbing non-integrin-mediated DC modulation; and accumulating evidence shows that in addition to the bacteria themselves, secreted components are capable of exerting immunomodulatory effects.

Urogenital Niche-Specific Mechanisms (Strain GR-1)

L. rhamnosus GR-1 is a probiotic strain isolated from a healthy female urethra; this strain has been shown to adhere well to urogenital epithelial and vaginal cells in vitro, and to temporarily colonize the human vagina and intestine following oral uptake; the fact that oral application of L. rhamnosus GR-1 can result in vaginal colonization is of interest in view of the natural ascension of lactobacilli from the gastrointestinal tract to the vagina.

For the first time, an important role for a novel lectin-like protein in the adhesion capacity and host cell-specific interaction of a vaginal probiotic Lactobacillus strain has been discovered, with an additional role in pathogen inhibition. GR-1 and RC-14 are well-characterized urogenital isolates selected on the basis of their probiotic properties at this site, while LGG possesses characteristics considered more important for an intestinal probiotic.

Strain GR-1 was found to persist in the vaginal tract for up to 19 days after vaginal instillation, while L. rhamnosus GG was detectable for up to 5 days post-administration. This distinction in persistence underscores the importance of strain selection for site-specific probiotic activity.

5. Scientific Evidence by Area of Use

5.1 Antibiotic-Associated Diarrhea (AAD)

This is the most thoroughly studied indication for LGG. A systematic review and meta-analysis included twelve RCTs (1,499 participants); treatment with LGG compared with placebo or no additional treatment reduced the risk of AAD in patients treated with antibiotics from 22.4% to 12.3% (11 RCTs, n = 1,308, relative risk [RR]: 0.49, 95% confidence interval [CI]: 0.29–0.83, low quality of evidence [QoE]).

In adults, the difference was not significant (six RCTs, n = 863, RR 0.48, 95% CI 0.20–1.15; low QoE), except for a subset of patients receiving antibiotics as part of Helicobacter pylori eradication therapy (four RCTs, n = 280, RR 0.26, 95% CI 0.11–0.59; low QoE).

The meta-analysis shows that LGG is effective in preventing antibiotic-associated diarrhea in children and adults treated with antibiotics for any reason; however, the quality of evidence is moderate to low. Earlier reviews were consistent with this direction: six trials met all eligibility requirements, and four of the six trials found a significant reduction in the risk of antibiotic-associated diarrhea with co-administration of LGG.

Evidence strength: Moderate benefit in children; statistically significant in pooled analysis; evidence quality rated low to moderate by GRADE criteria.

5.2 Acute Infectious Diarrhea (Pediatric)

In clinical trials, LGG (ATCC 53013) has been used to treat diarrhea; however, recent randomized controlled trials found no evidence of a beneficial effect of LGG treatment. Although previous studies reported that LGG is an effective therapeutic agent for acute diarrhea in children, a recent large, high-quality RCT found no adequate evidence of a beneficial effect of LGG treatment.

A meta-analysis of three randomized, controlled trials showed that the administration of LGG to children for the duration of hospital stay was associated with significantly lower rates of healthcare-associated diarrhea and symptomatic rotavirus gastroenteritis compared to placebo.

Evidence strength: Mixed and evolving. Earlier meta-analyses showed benefit; a large recent high-quality RCT did not confirm efficacy. The evidence base is now considered inconclusive for acute infectious diarrhea in children, and findings depend heavily on the specific study population and setting.

5.3 Irritable Bowel Syndrome (IBS)

Several controlled trials have investigated the effects of Lactobacillus rhamnosus GG on the symptoms of IBS in adults and in children; these studies have suggested that L. rhamnosus GG is not effective in the treatment of common intestinal discomfort in adults, but it may offer some help to children suffering from IBS.

In a meta-analysis of pediatric studies, the intensity of pain was significantly reduced in the overall study population and in the IBS subgroup; the frequency of pain was significantly reduced in the IBS subgroup only; the use of LGG was concluded to moderately increase treatment success in children with abdominal pain-related functional gastrointestinal disorders.

Clinically, LGG has been shown to improve IBS symptoms, delay onset of pouchitis after surgery for ulcerative colitis, and maintain remission in ulcerative colitis.

Evidence strength: Modest positive evidence in pediatric IBS (abdominal pain); evidence for adult IBS is not convincing based on current controlled trials. The evidence is preliminary and mixed.

5.4 Atopic Dermatitis and Allergy Prevention

In a study published in The Lancet, Kalliomäki and colleagues showed that the combination of prenatal maternal (2–4 weeks) and postnatal pediatric (6 months) LGG treatment (10¹⁰ CFU daily, capsules or in water) in families with a history of atopic disease significantly lowered the risk of eczema at the ages of 2, 4, and 7. However, allergic rhinitis and asthma tended to be more common in the LGG-treated group and no significant differences were found in incidence of cow milk allergy; moreover, Kopp and colleagues could not repeat the beneficial results against eczema using a similar protocol and concentration, and the reason for these different outcomes is unknown, though it is thought that the different genetic background of the tested populations (Finnish versus German) might play a role.

The daily doses of LGG used across included RCTs ranged from 1.0 × 10⁹ colony forming units (CFU) to 1.8 × 10¹⁰ CFU, with sample sizes ranging from 105 to 250. In clinical trials, infants aged 0–2 years had a reduced incidence of atopic eczema when their mothers had been administered LGG during pregnancy, and the preventive effect of LGG extended to 4 years.

A meta-analysis of five RCTs with 889 subjects concluded that LGG was ineffective for the primary prevention of eczema in children, when given both prenatally and postnatally.

Evidence strength: Conflicting. Some individual RCTs show benefit for eczema prevention when given perinatally; a meta-analysis of five RCTs found no effect. Results appear population-dependent and are not sufficiently consistent to support a general recommendation. Evidence is considered preliminary and mixed.

5.5 Urogenital Health (Strain GR-1)

Lactobacillus rhamnosus GR-1 and L. fermentum RC-14 are well-characterized probiotic strains with efficacy in the prevention and treatment of urogenital infections in women. A randomized, placebo-controlled trial of 64 healthy women given daily oral capsules of Lactobacillus rhamnosus GR-1 and Lactobacillus fermentum RC-14 for 60 days showed no adverse effects; microscopy analysis showed restoration from asymptomatic bacterial vaginosis microflora to a normal lactobacilli colonized microflora in 37% of women during lactobacilli treatment compared to 13% on placebo (P = 0.02).

To determine the effect of Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 administered orally twice daily for 12 weeks on the vaginal microbiota of pregnant women, a double-blind, placebo-controlled, randomized trial was performed in 86 asymptomatic pregnant women with intermediate or bacterial vaginosis Nugent scores at 13 weeks; after drop-outs, 32 women receiving probiotics and 34 receiving placebo completed the study; the Nugent score returned to normal in 30% of the women in both groups at 28 weeks and was maintained until 35 weeks.

Systematic reviews indicate moderate-quality evidence for urogenital health benefits, though larger long-term studies are needed to establish optimal dosing protocols.

Evidence strength: The strain GR-1 (in combination with L. reuteri RC-14) shows moderate-quality clinical evidence for restoration of vaginal flora in bacterial vaginosis. Effect size in some trials is modest. Evidence is stronger for microbiological endpoints (flora normalization) than for clinical symptom resolution. Larger confirmatory trials are still needed.

5.6 Healthcare-Associated and Rotavirus Gastroenteritis Prevention

A meta-analysis of three randomized, controlled trials showed that administration of LGG to children for the duration of hospital stay was associated with significantly lower rates of healthcare-associated diarrhea and symptomatic rotavirus gastroenteritis compared to placebo; LGG treatment has also been shown to reduce abdominal pain in children with functional gastrointestinal disorders, such as irritable bowel syndrome.

Evidence strength: Preliminary to moderate; based on a limited number of RCTs. The finding is consistent but derived from a small pool of trials.

5.7 Inflammatory Bowel Disease (IBD)

Clinically, LGG has been shown to delay onset of pouchitis after surgery for ulcerative colitis and maintain remission in ulcerative colitis. However, the clinical evidence base for LGG in IBD is limited in scope and scale, and these findings should be regarded as preliminary. Large well-powered RCTs specifically for IBD indications are lacking.

Evidence strength: Very preliminary; mostly small trials and mechanistic studies. Not sufficient to support broad clinical recommendations at this time.

6. Body Systems Associated with L. rhamnosus

• Gastrointestinal tract: Prevention and treatment of diarrhea (antibiotic-associated, nosocomial, rotavirus); IBS symptom management; IBD remission maintenance; gut barrier function improvement.
• Immune system: Modulation of host immune responses, including inhibition of pathogens and improvement of the epithelial barrier function.
• Urogenital tract: Colonization of the genito-urinary tract providing protective effects against infections such as urinary tract infections and bacterial vaginosis.
• Skin/Atopic disease: In clinical trials, infants had a reduced incidence of atopic eczema when their mothers were administered LGG during pregnancy; L. rhamnosus is the most studied species of Lactobacillus.
• Mucosal immunity (intestinal): p40 promotes IgA production via upregulation of a proliferation-inducing ligand (APRIL) and stimulates mucin gene expression and production.

7. Dosage Forms and Doses Reported in Studies

Dosages for L. rhamnosus are expressed in colony forming units (CFU) rather than by weight. The following dosages are drawn directly from reported clinical research:

• Antibiotic-associated diarrhea prevention (adults and children): Trials in the primary meta-analysis used LGG in a population of 1,308 participants across 11 RCTs. Typical doses for AAD prevention: 1 × 10⁹–1 × 10¹⁰ CFU/day, started concurrently with antibiotic and continued through the course plus 1–2 weeks.
• Eczema prevention (perinatal): LGG was administered at 10¹⁰ CFU daily (capsules or in water) for 2–4 weeks prenatally and 6 months postnatally.
• Eczema prevention RCT dose range: Daily doses of LGG ranged from 1.0 × 10⁹ CFU to 1.8 × 10¹⁰ CFU across included RCTs.
• Vaginal flora restoration (GR-1 + RC-14, oral): Oral administration twice daily for 12 weeks was used in a pregnant women trial. A 12-week study of 100 participants used daily administration of 10⁹ CFU.
• Bacterial vaginosis (oral, 64-woman RCT): Daily oral capsules of L. rhamnosus GR-1 and L. fermentum RC-14 for 60 days were used.
• General clinical range: Optimal dosage ranges from 10⁹ to 10¹⁰ CFU/day, depending on the specific indication and population being treated; doses up to 10¹¹ CFU/day have been used safely in clinical trials.
• Infant formulations: Infant formulations often use 1 × 10⁸–1 × 10⁹ CFU.

8. Safety Considerations and Interactions

General Safety Profile

LGG is generally recognized as safe (GRAS) for most populations; common side effects are rare, with mild gastrointestinal symptoms such as bloating and gas reported in some individuals; no significant adverse events have been reported in large clinical trials.

Compelling evidence in favor of the safety of L. rhamnosus strain GG comes from Finnish surveillance data showing no increase in Lactobacillus bacteremia over the decade from 1990 to 2000 despite the increasing popularity of this specific probiotic; lactobacilli represented only 0.02% of all positive blood cultures. The absence of any change in the prevalence of Lactobacillus bacteremia, particularly that due to L. rhamnosus strain GG, is remarkable given that the consumption of LGG increased from 1 L per person per year in Finland to 6 L per person per year over the time period studied.

Risk in Immunocompromised Individuals

Increasing reports on Lactobacillus bacteremia-associated morbidity and mortality in immunocompromised patients have raised safety concerns about its use in this group. Mostly deemed as low-virulence or concomitant, Lactobacillus spp. might be an opportunistic pathogen in immunocompromised, transplant patients and might be related to increased mortality.

Other reported risk factors for Lactobacillus bacteremia include intravenous catheters, prior hospitalization or surgery, and broad-spectrum antibiotic use. Patients with loss of integrity of the intestinal mucosal barrier are also at increased risk; gut translocation and systemic dissemination of organisms may be the underlying pathogenesis for invasive infections in immunocompromised patients.

The FDA has identified immunosuppression, structural heart disease, inpatient status, pregnancy, and potential for translocation of probiotic across the bowel wall as factors potentially conferring risk for adverse events in probiotic clinical trials.

Infection Risk and Central Venous Catheters

Bacteremia occurred in an intensive care setting in the presence of a central venous catheter; experts recommend the use of scrupulous hand hygiene when manipulating central venous catheters after handling probiotic preparations.

Intra-Species Variation and Potential Harm

A unique, clinically relevant clade comprising L. rhamnosus isolates from dental pulp infection together with isolates from bronchoalveolar lavage of a critical care patient has been uncovered, suggesting that intra-species variation within L. rhamnosus can correlate to harmful as well as beneficial outcomes. This highlights that not all strains of L. rhamnosus are equivalent in their safety or benefit profile.

Probiotic–Antibiotic Interactions

LGG does not have significant drug interactions but may reduce antibiotic-associated gastrointestinal side effects. Because LGG is a live bacterium, simultaneous administration with antibiotics may reduce viable counts; to preserve probiotic viability, administration is typically timed separately from the antibiotic dose, though this practice varies across clinical trials.

Harms Reporting Limitations

Harms reporting in published reports of RCTs assessing probiotics, prebiotics, and synbiotics are often lacking or inadequate, and it cannot be broadly concluded that these interventions are safe without reporting safety data. This is an important methodological caveat that limits definitive safety conclusions across the entirety of the LGG clinical literature.

Regulatory Status

LGG is generally marketed as a dietary supplement under the Dietary Supplement Health and Education Act (DSHEA) in the US, with the manufacturer responsible for compliance with labeling and Good Manufacturing Practice requirements. The NCCIH (National Center for Complementary and Integrative Health) and other NIH bodies acknowledge potential benefits of probiotics in select conditions but emphasize strain specificity and limitations of evidence, and they recommend further high-quality research.

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