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Clinical Trials in China / NCT05791604
Recruiting Not applicable

The Intervention of Obesity in Children With Prader-Willi Syndrome Using Prebiotics and Probiotics

NCT05791604 · tracked via the Priya Life Science China tracker
Sponsor
Children's Hospital of Fudan University
Phase
Not applicable
Started
2023-04-01
Last updated
2026-07-06

Condition(s) studied

Prader-Willi Syndrome

Investigational drug(s) / intervention(s)

probiotics including B. lactis B420, B. lactis HN019, B. animalis Bb-12, L. rhamnosus GGPrebiotics with galactomannan and oligofructose

probiotics including B. lactis B420, B. lactis HN019, B. animalis Bb-12, L. rhamnosus GG: Take probiotics, 2g each time, twice a day, for 12 weeks

Prebiotics with galactomannan and oligofructose: Take probiotics, 2g each time, twice a day, for 12 weeks Take prebiotics, 25g each time, twice a day, for 12 weeks

Study 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

Sex
ALL
Min age
3 Years
Max age
10 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Children's Hospital of Fudan University Shanghai Shanghai Municipality Recruiting

More Children's Hospital of Fudan University trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05791604 on ClinicalTrials.gov ↗ ← All trials in China