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Study on the Efficacy of Probiotics in the Treatment of Childhood Obesity and Their Effects on Gut Microbiota
Sponsor: Min-Tze LIONG
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
Conditions
Interventions
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.
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