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

May 6, 2026 updated by: Peking University Third Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Allergic diseases are a major global public health problem, affecting approximately 30%-40% of the population. Food allergy (FA) often represents the starting point of the atopic march in children and can subsequently progress to atopic dermatitis, asthma, allergic rhinitis, and other conditions, severely impacting quality of life. Early life is a critical "window period" for the development and maturation of the immune system, in which the gut microbiota plays a central role. The interaction between the gut microbiota and the host immune system is essential for the establishment of immune tolerance.

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. The underlying mechanism may involve antibiotic-induced disruption of the gut microbiota, which in turn affects immune balance and skews the immune response toward a Th2-dominant (allergy-prone) phenotype. However, the specific host-microbiota interactions involved have not yet been fully elucidated.

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 secretory IgA 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 on the development of allergic diseases after antibiotic exposure.

The study plans to enroll infants with early-life antibiotic exposure as the study population. Starting at 1 month of age, they will be randomly assigned to a probiotic intervention group or a placebo group, while infants who have never received antibiotics will be included as a control group.

Infants in the intervention group will receive an oral probiotic formulation for 8 weeks, whereas those in the placebo group will receive a placebo without probiotics. During the one-year follow-up period, the occurrence of food allergic diseases in each group will be documented in detail, including the time of onset, type, and severity of symptoms. In addition, growth and development indicators, gut microbiota composition, and metabolomic profiles will be regularly monitored to further explore the potential mechanisms of action of the probiotic intervention.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Juan Zhang, Medical Doctor
  • Phone Number: +8615611968716
  • Email: arbooo@126.com

Study Contact Backup

  • Name: Nini Dai, Medical Doctor
  • Phone Number: +8618801120799
  • Email: 1445693658@qq.com

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100191
        • Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
The control group consists of full-term healthy newborns who have not received antibiotics within 30 days after birth. No intervention will be given; they will only be followed up for the occurrence of allergic diseases and infectious diseases within the first year of life. During the follow-up period, four stool samples will be collected for the analysis of gut microbiota and their metabolites.
Experimental: Probiotic intervention group
The probiotic intervention group will recruit full-term newborns who have received antibiotics within 30 days after birth. Starting at 5 weeks of age, they will receive an 8-week course of an oral probiotic mixture (containing Bifidobacterium longum subsp. infantis R0033, Lactobacillus helveticus R0052, and Bifidobacterium bifidum R0071). They will be followed up for the occurrence of allergic diseases and infectious diseases within the first year of life. During the follow-up period, four stool samples will be collected for the analysis of gut microbiota and their metabolites.
Dietary supplement: Probiotic mixture
Oral probiotic mixture for 8 weeks, once daily, one sachet per day
Placebo Comparator: Placebo group
The placebo group will recruit full-term newborns who have received antibiotics within 30 days after birth. Starting at 5 weeks of age, they will receive an 8-week course of an oral placebo without the probiotic. They will be followed up for the occurrence of allergic diseases and infectious diseases within the first year of life. During the follow-up period, four stool samples will be collected for the analysis of gut microbiota and their metabolites.
Other: Placebo
Oral a placebo without probiotics for 8 weeks, once daily, one sachet per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of allergic diseases in infants
Time Frame: Follow up until the enrolled infants reach 1 year of age.
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.
Follow up until the enrolled infants reach 1 year of age.
Changes in gut microbiota composition in the antibiotic-exposed group
Time Frame: At enrollment (1 month of age) and at 3, 6, and 12 months of age
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.
At enrollment (1 month of age) and at 3, 6, and 12 months of age
Changes in fecal metabolites in infants of the probiotic intervention group
Time Frame: At 3, 6, and 12 months of age
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.
At 3, 6, and 12 months of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Growth curves of infants in the antibiotic-exposed group and the control group
Time Frame: At 3, 6, 9, and 12 months of age.
Compare the growth curves and developmental parameters between the antibiotic-exposed group and the control group.
At 3, 6, 9, and 12 months of age.
Proportion of infectious diseases in infants of the antibiotic-exposed group and the control group
Time Frame: Follow up until the infant reaches 1 year of age.
Compare the frequency, types, and proportion of infectious diseases between the antibiotic-exposed group and the control group.
Follow up until the infant reaches 1 year of age.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 17, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

April 8, 2026

First Submitted That Met QC Criteria

April 8, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00006761-M20251233
  • CON202602149245 (Other Grant/Funding Number: Biostime (Guangzhou) Health Products Ltd)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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