The Intervention of Obesity in Children With Prader-Willi Syndrome Using Prebiotics and Probiotics
Recruiting · NCT05791604 · Interventional (participants receive a specific treatment) · Lead sponsor: Children's Hospital of Fudan University
View the official record on ClinicalTrials.gov →Interventions studied
Prebiotics with galactomannan and oligofructoseprobiotics including B. lactis B420, B. lactis HN019, B. animalis Bb-12, L. rhamnosus GG
What this trial is about
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.
Who can take part
Age range
3 Years to 10 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Children's Hospital of Fudan University - Shanghai, Shanghai Municipality, China