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

NCT ID: NCT05791604

Last Updated: 2024-05-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2026-07-31

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.

Detailed 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.

Conditions

Prader-Willi Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Probiotics group

Take probiotics during the study

Group Type: EXPERIMENTAL

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

Intervention Type: DIETARY_SUPPLEMENT

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

Probiotics and prebiotics group

Take probiotics and prebiotics during the study

Group Type: EXPERIMENTAL

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

Intervention Type: DIETARY_SUPPLEMENT

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

Prebiotics with galactomannan and oligofructose

Intervention Type: DIETARY_SUPPLEMENT

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

Control group

Take placebo food during the study

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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

Intervention Type: DIETARY_SUPPLEMENT

Prebiotics with galactomannan and oligofructose

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

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei Lu, Dr

Role: STUDY_DIRECTOR

Children's Hospitial of Fudan Univeristy

Locations

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wei Lu, Dr

Role: CONTACT

wei_lu@fudan.edu.cn

86-021-64933281

Facility Contacts

Wei Lui

Role: primary

wei_lu@fudan.edu.cn

86-021-64933281

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

PREPROPWS

Identifier Type: -

Identifier Source: org_study_id