Actively Recruiting

Phase Not Applicable
Age: 3Years - 10Years
All Genders
NCT05791604

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

Led by Children's Hospital of Fudan University · Updated on 2026-03-27

60

Participants Needed

1

Research Sites

173 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 3Years - 10Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 3 to 10 years with a confirmed genetic diagnosis of Prader-Willi syndrome
  • Diagnosis consistent with obesity criteria
  • Not participating in other research projects currently or within the past three months
  • Parents agree to participation and sign informed consent
Not Eligible

You will not qualify if you...

  • Using weight loss drugs or other known drugs affecting weight outside this study's intervention
  • Use of antibiotics for 3 or more days within one month before the study
  • Use of probiotics for 3 or more days within one month before the study
  • Liver or kidney insufficiency with enzyme or creatinine levels over twice the normal limit
  • Gastrointestinal diseases affecting digestion or absorption, including severe diarrhea or constipation
  • Surgery within one year before the study (excluding appendicitis and hernia surgery)
  • Having hepatitis B, active tuberculosis, AIDS, or other infectious diseases
  • Having mental illness and taking psychotropic drugs such as antidepressants

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Actively Recruiting

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Research Team

W

Wei Lu, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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