Using prebiotics and probiotics to manage obesity in children with Prader-Willi syndrome

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

This study is testing whether giving probiotics and prebiotics can help children with Prader-Willi syndrome manage their weight and appetite better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 3 Years to 10 Years
• Sex: All
• Sponsor: Children's Hospital of Fudan University (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05791604 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness and safety of probiotics and prebiotics in controlling appetite and weight gain in children diagnosed with Prader-Willi syndrome (PWS). Participants will be divided into three groups, receiving either probiotics, a combination of probiotics and prebiotics, or a placebo. The study aims to observe changes in body weight, gut microbiota structure, and metabolic levels over the course of the intervention. Given the lack of effective treatments for obesity in PWS, this approach leverages emerging evidence linking gut microbiota to obesity management.

Who should consider this trial

Good fit: Ideal candidates are pre-adolescent children diagnosed with Prader-Willi syndrome and meeting obesity criteria.

Not a fit: Patients who have recently used weight loss drugs or antibiotics, or those with gastrointestinal diseases affecting digestion, may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could provide a novel method for managing obesity and appetite in children with Prader-Willi syndrome.

How similar studies have performed: While studies on probiotics and prebiotics for obesity management are emerging, this specific approach in PWS is novel and has not been extensively tested.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Children's Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Wei Lu, Dr

Conditions Prader-Willi Syndrome; Prader-Willi syndrome; Probiotics; Prebiotics