Actively Recruiting
The Intervention of Obesity in Children With Prader-Willi Syndrome Using Prebiotics and Probiotics
Led by Children's Hospital of Fudan University · Updated on 2026-03-27
60
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Prader-Willi syndrome (PWS) is a rare genetic disease, with hyperappetite and severe obesity. At present, there is no effective drugs and interventions to help control the appetite of PWS patients. More and more evidence has shown that gut microbiota is closely related to obesity. Probiotics and prebiotics can improve the structure of gut microbiota, thus improve blood lipid levels and other biochemical indicators of obese people. Therefore, this study intends to explore the effectiveness and safety of probiotics and prebiotics in controlling appetite and weight gain of PWS children.
CONDITIONS
Official Title
The Intervention of Obesity in Children With Prader-Willi Syndrome Using Prebiotics and Probiotics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 3 to 10 years with a confirmed genetic diagnosis of Prader-Willi syndrome
- Diagnosis consistent with obesity criteria
- Not participating in other research projects currently or within the past three months
- Parents agree to participation and sign informed consent
You will not qualify if you...
- Using weight loss drugs or other known drugs affecting weight outside this study's intervention
- Use of antibiotics for 3 or more days within one month before the study
- Use of probiotics for 3 or more days within one month before the study
- Liver or kidney insufficiency with enzyme or creatinine levels over twice the normal limit
- Gastrointestinal diseases affecting digestion or absorption, including severe diarrhea or constipation
- Surgery within one year before the study (excluding appendicitis and hernia surgery)
- Having hepatitis B, active tuberculosis, AIDS, or other infectious diseases
- Having mental illness and taking psychotropic drugs such as antidepressants
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
W
Wei Lu, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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