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

Last updated: May 10, 2024
Sponsor: Children's Hospital of Fudan University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Severe Short Stature

Hypogonadism

Treatment

Prebiotics with galactomannan and oligofructose

probiotics including B. lactis B420, B. lactis HN019, B. animalis Bb-12, L. rhamnosus GG

Clinical Study ID

NCT05791604
PREPROPWS
  • Ages 3-10
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Pre-adolescent children with Prader Willi syndrome which were definitely diagnosedby gene testing.

  • Consistent with the diagnostic criteria for obesity.

  • Not participate in other research projects at present or three months before theresearch;

  • Agree to participate in the test and obtain the consent of their parents;voluntarily be the subjects and sign the informed consent form.

Exclusion

Exclusion Criteria:

  • Losing weight in ways other than the intervention measures of this project, such astaking 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 serumcreatinine indexes exceed 2 times the upper limit of the normal value set by thehospital);

  • Have gastrointestinal diseases affecting food digestion and absorption (such assevere diarrhea, constipation, severe gastrointestinal inflammation, activegastrointestinal ulcer, acute cholecystitis, etc.); severe diarrhea refers to waterystool 3 or more times a day and lasts for 3 or more days. severe constipation refersto defecation 2 or less times a week with difficulty in defecation;

  • Surgery was performed within 1 year before the study (except for appendicitis andhernia surgery);

  • Have hepatitis B, active tuberculosis, AIDS and other infectious diseases;

  • Those who are suffering from mental illness and are taking psychotropic drugs suchas antidepressants.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Prebiotics with galactomannan and oligofructose
Phase:
Study Start date:
April 01, 2023
Estimated Completion Date:
July 31, 2026

Study Description

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.

Connect with a study center

  • Children's Hospital of Fudan University

    Shanghai, Shanghai
    China

    Active - Recruiting

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