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Clinical Trials in China / NCT07448220
Active, not recruiting Phase 2

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

NCT07448220 · tracked via the Priya Life Science China tracker
Sponsor
Min-Tze LIONG
Phase
Phase 2
Started
2023-12-01
Last updated
2026-03-04

Condition(s) studied

Overweight , Obesity

Investigational drug(s) / intervention(s)

ProbioticPlacebo

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.

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.

Eligibility

Sex
ALL
Min age
3 Years
Max age
14 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Body Mass Index (BMI) percentile in children upon administration of probiotics or placebo as assessed anthropometrically — 8 weeks
    Differences in BMI percentile in children upon administration of probiotics or placebo

Trial sites (2)

FacilityCityRegionStatus
Nanxiang Hospital, Jiading District, Shanghai Jiading Shanghai Municipality
Universiti Sains Malaysia Pulau Pinang Pulau Pinang

More Min-Tze LIONG trials in China

Evaluation of the Clinical Efficacy of Antrrix Probiotics in Improving Recurrent Respiratory Infections in Infants and Young Children Recruiting
Integrated Study on Gut Microbiota, Immune Indicators, and Trace Elements in Children With Respiratory Tract Infections Starting soon
The Effect of Probiotics on Gut Microbiota Changes in Healthy Chinese Adults During Short-Term European Travel: A Randomised, Double-Blind, Placebo-Controlled Clinical Trial Starting soon
To Investigate the Effects of Bifidobacterium Animalis Subsp. Lactis XLTG11 on Growth and Development, Incidence of Allergy and Immune Function in Infants Recruiting
Effects of Probiotics on Respiratory Tract Infections in Children: A Randomized, Placebo-Controlled Interventional Study Enrolling by invitation

Other trials for the same condition

Study of UBT37034 Injection Recruiting
Phase 2 Study to Evaluate the Efficacy and Safety of MWN109 Injection in Non-Diabetic Participants With Overweight Active, not recruiting
A Study of Zovaglutide (ZT002 Injection) in Participants With Impaired Kidney Function and Healthy Participants Active, not recruiting
Phase 1 Clinical Study of MWN105 Injection in Participants With Overweight or Obesity Recruiting
Phase 3 Study of MWN109 Injection in Participants With Overweight or Obesity Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07448220 on ClinicalTrials.gov ↗ ← All trials in China