Early antibiotic exposure is an important environmental factor that disrupts the establishment of the infant gut microbiota and leads to microbial dysbiosis. Accumulating epidemiological evidence indicates that exposure to antibiotics early in life (including both prenatal and postnatal periods) is significantly associated with an increased risk of allergic diseases in childhood. As live microorganisms, probiotics hold potential as a preventive strategy against allergies due to their ability to stabilize the intestinal barrier and regulate immune balance (e.g., promoting Th1/Th2 balance, inducing regulatory T cells, and increasing sIgA secretion). However, current studies have mostly focused on general or high-risk infant populations. For the specific high-risk subgroup that has already been exposed to antibiotics early in life, high-quality randomized controlled trial evidence is still lacking regarding whether probiotic intervention can effectively reduce the incidence of allergies and whether it exerts its effects by reshaping the gut microbiota and metabolites disrupted by antibiotics.
This study focuses on breastfed infants who received antibiotics during the early postnatal period (within 30 days after birth) and aims to investigate the effect of a probiotic mixture containing Bifidobacterium longum subsp. infantis R0033, Lactobacillus helveticus R0052, and Bifidobacterium bifidum R0071 on the development of allergic diseases after antibiotic exposure.
Gestational age from 37 weeks to less than 41 weeks;
Birth weight between the 10th and 90th percentiles for gestational age;
Breastfed (exclusively breastfed after achieving stable feeding volume, with willingness to maintain exclusive breastfeeding for at least 3 months);
Postnatal age within 35 days; Consent to participate in this study.
Postnatal Apgar score <7;
Presence of severe congenital malformations or inherited metabolic diseases;
Use of probiotics by the infant or the mother within 2 weeks before enrollment.
Parallel
Probiotic mixture
Dietary supplementOral probiotic mixture for 8 weeks, once daily, one sachet per day
Placebo
Other interventionOral a placebo without probiotics for 8 weeks, once daily, one sachet per day.
Incidence of allergic diseases in infants
Compare the incidence of allergic diseases between the antibiotic-exposed group and the control group, and analyze the effects of antibiotic exposure intensity, frequency, and type on the development of allergic diseases. Furthermore, compare the incidence of allergic diseases among the probiotic intervention group, the placebo group, and the control group.
Changes in gut microbiota composition in the antibiotic-exposed group
Compare the changes in gut microbiota composition of infants in the antibiotic-exposed group at enrollment (1 month of age) and at 3, 6, and 12 months of age, compare the differences in gut microbiota composition among the three groups, and analyze the effect of antibiotic exposure intensity on gut microbiota composition.
Changes in fecal metabolites in infants of the probiotic intervention group
Compare the changes in fecal metabolites between the probiotic intervention group and the placebo group, and explore the potential mechanisms by which specific probiotic intervention induces alterations in gut metabolites.
Growth curves of infants in the antibiotic-exposed group and the control group
Compare the growth curves and developmental parameters between the antibiotic-exposed group and the control group.
Proportion of infectious diseases in infants of the antibiotic-exposed group and the control group
Compare the frequency, types, and proportion of infectious diseases between the antibiotic-exposed group and the control group.
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