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

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.

NCT Number	NCT07448220
Lead Sponsor	Min-Tze LIONG Collaborators: Nanxiang Hospital Shanghai
Conditions	Overweight , Obesity
Enrollment	60 participants
Start Date	2023-12-01
Primary Completion	2026-04-01 (estimated)
Study Completion	2026-04-01 (estimated)
Updated on ClinicalTrials.gov	2026-03-04