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Study on the Efficacy of Probiotics in the Treatment of Childhood Obesity and Their Effects on Gut Microbiota

NCT07448220 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-04

No results posted yet for this study

Summary

This interventional study aims to evaluate the efficacy of a probiotics supplementation (Bifidobacterium longum subsp. longum Dipro-O and Bifidobacterium longum subsp. longum Dipro-X; dipro Gracfor PROBIOTICS FAST MELT) in treating childhood obesity and its impact on gut microbiota. The study will enroll 60 overweight or obese children aged 3 to 14 years. Participants will be randomly assigned to either a treatment group receiving lifestyle intervention combined with an oral Bifidobacterium preparations for 8 weeks, or a control group receiving lifestyle intervention alone. The primary outcome is the change in sex-specific BMI-for-age percentiles. Secondary outcomes include changes in height, weight, waist circumference, quality of life satisfaction, and alterations in gut microbiota composition analyzed via 16S rRNA gene sequencing.

Conditions

  • Overweight , Obesity

Interventions

DIETARY_SUPPLEMENT

Probiotic

A sachet of Bifidobacterium longum subsp. longum dipro O + Bifidobacterium longum subsp. longum dipro X, at a dose of 5 × 10\^9 CFU per day.

DIETARY_SUPPLEMENT

Placebo

A sachet of maltodextrin per day.

Sponsors & Collaborators

  • Nanxiang Hospital Shanghai

    collaborator UNKNOWN

  • Min-Tze LIONG

    lead OTHER

Principal Investigators

  • Aihua Zhang, MD. · Nanxiang Hospital, Jiading District, Shanghai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2026-04-01
Completion
2026-04-01

Countries

  • China
  • Malaysia

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 NCT07448220 on ClinicalTrials.gov