ClinicalTrials.gov record NCT05791604
The Intervention of Obesity in Children With Prader-Willi Syndrome Using Prebiotics and Probiotics
The Safety and Effectiveness Study of Prebiotics and Probiotics in the Intervention of Obesity in Children With Prader-Willi Syndrome
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This randomized, single-masked treatment study tests probiotics alone, probiotics plus prebiotics, or placebo in children with Prader-Willi syndrome who meet criteria for obesity. Treatments are taken for 12 weeks and outcomes measured include BMI, body composition, gut microbiota, and metabolic lab markers. The study examines the safety and effectiveness of these dietary supplements for controlling appetite and weight gain.
What it is studying. The study is testing the safety and effectiveness of giving specified oral probiotics, with or without added prebiotics, to children with Prader-Willi syndrome who have obesity. It will measure changes in body mass index, body composition, gut microbiota composition, and metabolic indicators over the study period.
What the researchers hope to learn. To collect data on whether these specific probiotics, alone or combined with prebiotics, affect appetite, weight gain, body composition, gut microbiota, and metabolic markers in children with Prader-Willi syndrome, and to assess safety during the study period.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Dietary supplement
- probiotics including B. lactis B420, B. lactis HN019, B. animalis Bb-12, L. rhamnosus GG
- Prebiotics with galactomannan and oligofructose
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
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, probiotics+probiotics or placebo treatment, and observe the changes in body weight, the structure of gut microbiota and metabolic level.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants are randomized to one of three groups (probiotics; probiotics plus prebiotics; or placebo) and take the assigned product(s) twice daily for 12 weeks. They will attend study visits at baseline, 4 weeks and 12 weeks for measurements (weight, height, waist circumference, body composition) and for blood tests (for glucose, insulin, HbA1c and cholesterol/lipids); fingertip blood for glucose is used as stated. Stool samples will be collected to analyze gut microbiota, and caregivers will report bowel habits, abdominal pain and flatulence during follow‑up visits.
How the study is structured. Randomized, parallel-group, single-masked interventional study with three arms: probiotics, probiotics plus prebiotics, and placebo. Participants take the assigned dietary supplements daily for 12 weeks (probiotics given twice daily; prebiotics given twice daily in the combined arm). Key measurements are taken at 4 weeks and 12 weeks and include weight, height, body composition, stool samples for gut microbiota, and blood metabolic tests.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on Prader-Willi syndrome
Important dates
- Study start
- Apr 1, 2023
- Primary completion
- Mar 31, 2028 (estimated)
- Study completion
- Jul 31, 2029 (estimated)
- Target enrollment
- 60 participants (estimated)
- Last updated on registry
- Jul 6, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Children's Hospital of Fudan University
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Wei Lu, Dr 📞 86-021-64933281 ✉ wei_lu@fudan.edu.cn
Participating sites (1)
- Children's Hospital of Fudan UniversityRecruiting
Shanghai, Shanghai Municipality · China
- Wei Lui · 86-021-64933281 · wei_lu@fudan.edu.cn
Terms used on this page · explanations by MedicalUpdates.ai
- informed consent form
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- placebo
- A treatment that looks like the study treatment but contains no active ingredient. Some participants receive it instead of the study treatment, usually without knowing which they got.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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