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

NCT05791604 | Recruiting

• 1 other identifier: PREPROPWS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prader-Willi Syndrome

Keywords

Prader-Willi syndrome; Probiotics; Prebiotics

Outcome Measures

Primary Outcomes (1)

• Body mass index

  Body mass index is calculated as weight (kg)/\[Height (m)\^2\]. Weight and height will be combined to report BMI in kg/m\^2.

  12 weeks

Secondary Outcomes (16)

• Body composition

  4 weeks and 12 weeks

• The structure of gut microbiota

  4 weeks and 12 weeks

• Height

  4 weeks and 12 weeks

• Weight

  4 weeks and 12 weeks

• Waist circumference

  4 weeks and 12 weeks

Study Arms (3)

Probiotics group

EXPERIMENTAL

Take probiotics during the study

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

Probiotics and prebiotics group

EXPERIMENTAL

Take probiotics and prebiotics during the study

Dietary Supplement: probiotics including B. lactis B420, B. lactis HN019, B. animalis Bb-12, L. rhamnosus GG; Dietary Supplement: Prebiotics with galactomannan and oligofructose

Control group

NO INTERVENTION

Take placebo food during the study

Interventions

Prebiotics with galactomannan and oligofructose DIETARY_SUPPLEMENT

Take probiotics, 2g each time, twice a day, for 12 weeks Take prebiotics, 25g each time, twice a day, for 12 weeks

Probiotics and prebiotics group

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

Take probiotics, 2g each time, twice a day, for 12 weeks

Probiotics and prebiotics group; Probiotics group

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Prader-Willi Syndrome

Interventions

Prebiotics; galactomannan; oligofructose

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Imprinting Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Study Officials

• Wei Lu, Dr

  Children's Hospitial of Fudan Univeristy

  STUDY DIRECTOR

Central Study Contacts

Wei Lu, Dr

CONTACT

86-021-64933281; wei_lu@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 30, 2023
• Study Start: April 1, 2023
• Primary Completion: March 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)