Probiotic Intervention on the Development of Allergic Diseases in Infants Exposed to Antibiotics Early in Life

Starting soon · Not applicable · Has a placebo group

Conditions studied: Antibiotic, Allergic Diseases, Infants, Probiotic

In brief

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.

Key facts

Study ID

NCT07532421

Run by

Peking University Third Hospital

People needed

400

Starts

2026-04-17

Expected to finish

2027-10-31

Last updated by the study team

2026-05-11

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Peking University Third Hospital — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

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