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ACTIVE NOT RECRUITING
NCT07448220
PHASE2

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

Sponsor: Min-Tze LIONG

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

3 Years - 14 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-12-01

Completion Date

2026-04-01

Last Updated

2026-03-04

Healthy Volunteers

Yes

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.

Locations (2)

Nanxiang Hospital, Jiading District, Shanghai

Jiading, Shanghai Municipality, China

Universiti Sains Malaysia

Pulau Pinang, Pulau Pinang, Malaysia