The Safety and Effectiveness Study of Prebiotics and Probiotics in the Intervention of Obesity in Children With Prader-Willi Syndrome

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 10
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Children's Hospital of Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Wei Lu, Dr
wei_lu@fudan.edu.cn
86-021-64933281
Time Frame
Start Date: 2023-04-01
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 60
Treatments
Experimental: Probiotics group
Take probiotics during the study
Experimental: Probiotics and prebiotics group
Take probiotics and prebiotics during the study
No_intervention: Control group
Take placebo food during the study
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital of Fudan University

This content was sourced from clinicaltrials.gov