Synopsis

Source of validity: Scientific
Rating (out of 5): 2

Dialyzable Leukocyte Extract (DLE) is a preparation derived from human leukocytes and contains low-molecular-weight substances purported to modulate immune responses. Its use in supporting or treating bacterial infections is primarily based on its immunomodulatory effects, which have been observed in various preclinical and some clinical studies. The rationale is that DLE can enhance the body's immune system, thus improving the host's ability to fight bacterial pathogens.

Several small clinical studies, particularly in Latin America, have suggested that DLE may provide benefit as an adjuvant therapy in chronic or recurrent bacterial infections, such as tuberculosis and respiratory tract infections. For example, a few trials have reported enhanced lymphocyte responses and a reduction in infection rates when DLE is used alongside conventional antibiotic therapies. However, the quality of these studies is variable, with many suffering from small sample sizes, lack of blinding, and poor methodological rigor.

Systematic reviews and meta-analyses are limited, and no large, well-conducted randomized controlled trials have established DLE's efficacy for bacterial infections. Regulatory agencies such as the FDA do not recognize DLE as an approved treatment for any infection, and it is not included in mainstream clinical guidelines. Thus, while there is a scientific basis and some clinical evidence for its use, the overall quality and quantity of supporting data are modest, justifying a rating of 2 on the evidence scale.

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