NCT05791604Recruiting
The Intervention of Obesity in Children With Prader-Willi Syndrome Using Prebiotics and Probiotics
The Safety and Effectiveness Study of Prebiotics and Probiotics in the Intervention of Obesity in Children With Prader-Willi Syndrome
Source: ClinicalTrials.gov · Last updated 6 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 6 Mar 2023
- Start date
- 1 Apr 2023
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- Children's Hospital of Fudan University
- Diseases
- Obesity
- NCT number
- NCT05791604
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Apr 2023 to the primary completion date, 31 Mar 2028
- 1 site in 1 country
- 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
- Losing weight in ways other than the intervention measures of this project, such as taking weight loss drugs or known drugs that cause weight change;
- Use antibiotics within 1 month before the study and lasted for 3 days or more;
- Use probiotics within 1 month before the study and lasted for 3 days or more;
- Surgery was performed within 1 year before the study (except for appendicitis and hernia surgery);
Other illness
- Have gastrointestinal diseases affecting food digestion and absorption (such as severe diarrhea, constipation, severe gastrointestinal inflammation, active gastrointestinal ulcer, acute cholecystitis, etc.); severe diarrhea refers to watery stool 3 or more times a day and lasts for 3 or more days. severe constipation refers to defecation 2 or less times a week with difficulty in defecation;
- Have hepatitis B, active tuberculosis, AIDS and other infectious diseases;
- Those who are suffering from mental illness and are taking psychotropic drugs such as antidepressants.
Lab values
- Complicated with liver and renal insufficiency (alanine aminotransferase and serum creatinine indexes exceed 2 times the upper limit of the normal value set by the hospital);
Who the study is looking for
- Pre-adolescent children with Prader Willi syndrome which were definitely diagnosed by gene testing.
- Consistent with the diagnostic criteria for obesity.
- Not participate in other research projects at present or three months before the research;
- Agree to participate in the test and obtain the consent of their parents; voluntarily be the subjects and sign the informed consent form.
Age in the registry: 3 years to 10 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital Of Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.