Clinical trial

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

Active, not recruiting · Phase 2 · 2 countries · Registry ID NCT07448220

Active, not recruitingPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age3 Years to 14 Years

SexAll

Healthy volunteersAccepted

ConditionOverweight , Obesity

Full registry criteria

Inclusion Criteria: * Diagnostic Criteria (Refer to the "Expert Consensus on Diagnosis and Management of Childhood Obesity in China"): For children aged 2-5 years, refer to the "Growth Curve for Chinese Children and Adolescents Aged 0-18 Years" to determine the BMI cutoff points for overweight and obesity in Chinese children aged 2-5 years. For children aged 6-18 years, refer to the "Screening for Overweight and Obesity in School-Age Children and Adolescents" to determine the BMI cutoff points for overweight and obesity by age and gender in children aged 6-18 years. * Age: 3-14 years. * Fully informed consent: Parents or guardians have been fully informed of the clinical trial procedures, and both have signed the written informed consent form. Exclusion Criteria: * The child has chronic or severe systemic diseases. * The child has a family history of obesity-related metabolic or endocrine diseases. * The child has been diagnosed with psychological disorders or psychiatric diseases. * The child has used antibiotics or probiotic preparations within 4 weeks prior to enrollment. * The child was enrolled in other clinical studies 4 weeks prior to enrollment.

Treatments and study arms

Probiotic

Dietary Supplement

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

Dietary Supplement

A sachet of maltodextrin per day.

Primary outcomes

Body Mass Index (BMI) percentile in children upon administration of probiotics or placebo as assessed anthropometrically8 weeks

Differences in BMI percentile in children upon administration of probiotics or placebo

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Nanxiang Hospital, Jiading District, Shanghai🇨🇳 Jiading, Shanghai Municipality, China

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Universiti Sains Malaysia🇲🇾 Pulau Pinang, Pulau Pinang, Malaysia

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