Resilience to Antibiotic-induced Obesogenic Microbiota: Discovering Mechanism of Microbiota Modulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-08

Study Completion Date

2029-12-31

Brief Summary

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The aim is to study whether the microbiota of children who are exposed to antibiotics at birth could be modified by synbiotic supplement and thereby reduce the risk of obesity, chronic diseases and respiratory tract infections. A total of 125 mother-child pairs will be recruited in this randomized, double-blind, placebo-controlled study. Infants are randomized to receive either a synbiotic supplement or a placebo for 2 months, after which their growth and morbidity will be monitored at the research clinic for 2 years.

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Detailed Description

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Conditions

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Healthy Newborn Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, placebo-controlled trial

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Synbiotic

Bifidobacterium bifidum and human milk oligosaccharides (HMOs)

Group Type ACTIVE_COMPARATOR

Synbiotic Supplement

Intervention Type DIETARY_SUPPLEMENT

Bifidobacterium bifidum and human milk oligosaccharides (HMOs)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Maltodextrin

Interventions

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Synbiotic Supplement

Bifidobacterium bifidum and human milk oligosaccharides (HMOs)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Maltodextrin

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Pregnant women (n=125) and their newborn children who receive antibiotic treatment at delivery.

Exclusion Criteria

* Chorioamnionitis
* Pre-eclampsia and hepatogestosis
* Suspected malformation or serious condition of the foetus and neonates
* Serious infection or other conditions not permitting breast milk feeding

Minimum Eligible Age

2 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No