NCT05791604 The Intervention of Obesity in Children With Prader-Willi Syndrome Using Prebiotics and Probiotics
| NCT ID | NCT05791604 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Fudan University |
| Condition | Prader-Willi Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-04-01 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-04-01 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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; * 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); * 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; * Surgery was performed within 1 year before the study (except for appendicitis and hernia surgery); * 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.
Contact & Investigator
Wei Lu, Dr
STUDY DIRECTOR
Children's Hospitial of Fudan Univeristy
Frequently Asked Questions
Who can join the NCT05791604 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 10 Years, studying Prader-Willi Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05791604 currently recruiting?
Yes, NCT05791604 is actively recruiting participants. Contact the research team at wei_lu@fudan.edu.cn for enrollment information.
Where is the NCT05791604 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05791604 clinical trial?
NCT05791604 is sponsored by Children's Hospital of Fudan University. The principal investigator is Wei Lu, Dr at Children's Hospitial of Fudan Univeristy. The trial plans to enroll 60 participants.