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

Prader-Willi Syndrome Clinical Trial

Official title:

The Safety and Effectiveness Study of Prebiotics and Probiotics in the Intervention of Obesity in Children With Prader-Willi Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05791604
• Other study ID #: PREPROPWS
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: July 31, 2026

Study information

• Verified date: May 2024
• Source: Children's Hospital of Fudan University
• Contact: Wei Lu, Dr
• Phone: 86-021-64933281
• Email: wei_lu[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pediatric Obesity
• Prader-Willi Syndrome
• Syndrome

Intervention

Dietary Supplement:
• 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
• 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

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Body composition	Body composition including body fat percentage will be measured through body composition meter.	4 weeks and 12 weeks
Secondary	The structure of gut microbiota	The 16s rRNA genes of fecal samples were analyzed.	4 weeks and 12 weeks
Secondary	Height	The height is accurate to 0.1cm.	4 weeks and 12 weeks
Secondary	Weight	The weight is accurate to 0.1kg.	4 weeks and 12 weeks
Secondary	Waist circumference	The waist circumference is accurate to 0.1cm.	4 weeks and 12 weeks
Secondary	Glycosylated hemoglobin level	The glycosylated hemoglobin is accurate to 0.1%.	4 weeks and 12 weeks
Secondary	Fast triglyceride level	The fast triglyceride level will be measured by IMMULITE 1000 (Siemens,Germany).	4 weeks and 12 weeks
Secondary	Fast total cholesterol level	The fast total cholesterol level will be measured by IMMULITE 1000 (Siemens,Germany).	4 weeks and 12 weeks
Secondary	Fast low density lipoprotein level	The fast low density lipoprotein level will be measured by IMMULITE 1000 (Siemens,Germany).	4 weeks and 12 weeks
Secondary	Fast high density lipoprotein level	The fast high density lipoprotein level will be measured by IMMULITE 1000 (Siemens,Germany).	4 weeks and 12 weeks
Secondary	Defecation status	Care givers describe the defecation status in the past 1 week, including the frequency, nature, and color.	4 weeks and 12 weeks
Secondary	Abdominal pain	Care givers describe whether abdominal pain occurs, and if so, provide frequency.	4 weeks and 12 weeks
Secondary	Excessive flatulence	Care givers describe whether excessive flatulence occurs, and if so, provide frequency.	4 weeks and 12 weeks
Secondary	Fast insulin level	The fast insulin level will be measured by IMMULITE 1000 (Siemens,Germany).	4 weeks and 12 weeks
Secondary	Fast glucose level	The fast glucose level is detected by fingertip blood with blood glucose meter.	4 weeks and 12 weeks
Secondary	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.	4 weeks