The use of oral bacterial lysate in infants did not influence the rate of atopic dermatitis, allergic rhinitis, aero-allergen sensitization, or asthma development in childhood, according to study research published in Allergy.
The aim of this randomized, placebo-controlled trial (ISRCTN60475069) was to assess if an orally introduced bacterial lysate during infancy would affect the incidence of allergic diseases later in life. The study was based on theories that gut immune modulation decreases specific IgE and IgG, and therefore allergies, in animal models. For this study, infants with at least 1 parent with an allergy were given heat-killed, gram-negative Escherichia coli Symbio and gram-positive Enterococcus faecalis Symbio or a placebo 3 times a day from the age of 5 weeks to 7 months. Clinical evaluations for potential allergy development were completed between 7 months and 3 years of age, and again when the child was school-aged.
Of the 402 children who completed the school-age follow-up, 200 were in the test protocol and 202 were in the placebo protocol. Baseline characteristics were similar for the 2 cohorts. In the test protocol cohort, 11.0% of children developed atopic dermatitis, 35.0% developed allergic rhinitis, 9.0% developed asthma, and 46.5% developed allergic sensitization to common aero-allergens. In the placebo protocol cohort, 10.4% of children developed atopic dermatitis, 38.1% developed allergic rhinitis, 6.6% developed asthma, and 51.7% developed allergic sensitization to common aero-allergens. There were no significant differences found in the 2 cohorts, even after adjusting for potential variables and comorbidities.
The researchers concluded that “[a]pplying a bacterial lysate of heat-killed gram-negative Escherichia coli and gram-positive Enterococcus faecalis in early infancy during a period of 6 months does not influence the development of [atopic dermatitis], [allergic rhinitis], asthma and sensitization at school-age.”
Disclosure: This clinical trial was supported by Symbiopharm, Herborn. Please see the original reference for a full list of authors’ disclosures.
Roßberg S, Keller T, Icke K, et al. Orally applied bacterial lysate in infants at risk for atopy does not prevent atopic dermatitis, allergic rhinitis, asthma or allergic sensitization at school age: follow-up of a randomized trial [published online February 22, 2020]. Allergy. doi:10.1111/all.14247