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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prader-Willi Syndrome
• Intervention / Treatment: Dietary supplement: probiotics including B. lactis B420, B. lactis HN019, B. animalis Bb-12, L. rhamnosus GG; Dietary supplement: Prebiotics with galactomannan and oligofructose

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei Lu, Dr; Phone Number: 86-021-64933281; Email: wei_lu@fudan.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Children's Hospital of Fudan University
      • Contact: Wei Lui; Phone Number: 86-021-64933281; Email: wei_lu@fudan.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotics group; Take probiotics during the study	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
Experimental: Probiotics and prebiotics group; Take probiotics and prebiotics during the study	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; 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
No Intervention: Control group; Take placebo food during the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Investigators: Study Director: Wei Lu, Dr, Children's Hospitial of Fudan Univeristy

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: March 17, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Probiotics; Prader-Willi syndrome; Prebiotics
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Obesity; Imprinting Disorders; Syndrome; Pediatric Obesity; Prader-Willi Syndrome
• Other Study ID Numbers: PREPROPWS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: After applying to the researcher, the researcher will decide whether to share the data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No