Ignite Creation Date:
2024-05-06 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05791604
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2023-03-06
Brief Title:
The Intervention of Obesity in Children With Prader-Willi Syndrome Using Prebiotics and Probiotics
Sponsor:
Childrens Hospital of Fudan University
Organization:
Childrens Hospital of Fudan University
Study Overview
Official Title:
The Safety and Effectiveness Study of Prebiotics and Probiotics in the Intervention of Obesity in Children With Prader-Willi Syndrome
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Prader-Willi syndrome PWS is a rare genetic disease with hyperappetite and severe obesity Morbid obesity and related complications caused by hyperappetite are the most common causes of poor prognosis and death in PWS At present there is no effective drugs and interventions to help control the appetite of PWS patients At present 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 Participants will be divided into three groups receiving probiotics probioticsprobiotics or placebo treatment and observe the changes in body weight the structure of gut microbiota and metabolic level
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None