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

NCT07532421 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-05-11

No results posted yet for this study

Summary

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.

Conditions

  • Antibiotic
  • Allergic Diseases
  • Infants
  • Probiotic

Interventions

DIETARY_SUPPLEMENT

Probiotic mixture

Oral probiotic mixture for 8 weeks, once daily, one sachet per day

OTHER

Placebo

Oral a placebo without probiotics for 8 weeks, once daily, one sachet per day.

Sponsors & Collaborators

  • Peking University Third Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
35 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-17
Primary Completion
2027-09-30
Completion
2027-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07532421 on ClinicalTrials.gov