Probiotics and Prebiotics for Weight Gain in Children With Prader-Willi Syndrome
Tests probiotics and prebiotics to help control appetite and weight in children with Prader-Willi syndrome.
Plain-language title generated from the registry record
Registry title: The Intervention of Obesity in Children With Prader-Willi Syndrome Using Prebiotics and Probiotics
Key facts
- Where
- Shanghai, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 3 and 10 years old?
Source: NCT05791604, who can take part
Where in China
- Children's Hospital Of Fudan UniversityShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Children's Hospital of Fudan University
- Trial code
- NCT05791604
- Record updated
- 6 July 2026
- Original description
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.Read full original descriptionShow less
The Safety and Effectiveness Study of Prebiotics and Probiotics in the Intervention of Obesity in Children With Prader-Willi Syndrome
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.
Inclusion: 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.
Exclusion: 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); 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; 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).