NCT07448220Active, not recruitingPhase 2
Study on the Efficacy of Probiotics in the Treatment of Childhood Obesity and Their Effects on Gut Microbiota
Source: ClinicalTrials.gov · Last updated 4 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 23 Feb 2026
- Start date
- 1 Dec 2023
- Primary completion date
- 1 Apr 2026
- Lead sponsor
- Min-Tze LIONG
- Diseases
- Obesity
- NCT number
- NCT07448220
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 1 Dec 2023 to the primary completion date, 1 Apr 2026
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 3 years to 14 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanxiang Hospital, Jiading District, Shanghai Coordinator of this site? Confirm its status | Jiading | China | Unknown status |
| Universiti Sains Malaysia Coordinator of this site? Confirm its status | Pulau Pinang | Malaysia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.