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

Primary Purpose

Prader-Willi Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
probiotics including B. lactis B420, B. lactis HN019, B. animalis Bb-12, L. rhamnosus GG
Prebiotics with galactomannan and oligofructose
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prader-Willi Syndrome focused on measuring Prader-Willi syndrome, Probiotics, Prebiotics

Eligibility Criteria

3 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Hospital of Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Probiotics group

Probiotics and prebiotics group

Control group

Arm Description

Take probiotics during the study

Take probiotics and prebiotics during the study

Take placebo food during the study

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 6, 2023
Last Updated
May 7, 2023
Sponsor
Children's Hospital of Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05791604
Brief Title
The Intervention of Obesity in Children With Prader-Willi Syndrome Using Prebiotics and Probiotics
Official Title
The Safety and Effectiveness Study of Prebiotics and Probiotics in the Intervention of Obesity in Children With Prader-Willi Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prader-Willi Syndrome
Keywords
Prader-Willi syndrome, Probiotics, Prebiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotics group
Arm Type
Experimental
Arm Description
Take probiotics during the study
Arm Title
Probiotics and prebiotics group
Arm Type
Experimental
Arm Description
Take probiotics and prebiotics during the study
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Take placebo food during the study
Intervention Type
Dietary Supplement
Intervention Name(s)
probiotics including B. lactis B420, B. lactis HN019, B. animalis Bb-12, L. rhamnosus GG
Intervention Description
Take probiotics, 2g each time, twice a day, for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Prebiotics with galactomannan and oligofructose
Intervention Description
Take probiotics, 2g each time, twice a day, for 12 weeks Take prebiotics, 25g each time, twice a day, for 12 weeks
Primary Outcome Measure Information:
Title
Body mass index
Description
Body mass index is calculated as weight (kg)/[Height (m)^2]. Weight and height will be combined to report BMI in kg/m^2.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Body composition
Description
Body composition including body fat percentage will be measured through body composition meter.
Time Frame
4 weeks and 12 weeks
Title
The structure of gut microbiota
Description
The 16s rRNA genes of fecal samples were analyzed.
Time Frame
4 weeks and 12 weeks
Title
Height
Description
The height is accurate to 0.1cm.
Time Frame
4 weeks and 12 weeks
Title
Weight
Description
The weight is accurate to 0.1kg.
Time Frame
4 weeks and 12 weeks
Title
Waist circumference
Description
The waist circumference is accurate to 0.1cm.
Time Frame
4 weeks and 12 weeks
Title
Glycosylated hemoglobin level
Description
The glycosylated hemoglobin is accurate to 0.1%.
Time Frame
4 weeks and 12 weeks
Title
Fast triglyceride level
Description
The fast triglyceride level will be measured by IMMULITE 1000 (Siemens,Germany).
Time Frame
4 weeks and 12 weeks
Title
Fast total cholesterol level
Description
The fast total cholesterol level will be measured by IMMULITE 1000 (Siemens,Germany).
Time Frame
4 weeks and 12 weeks
Title
Fast low density lipoprotein level
Description
The fast low density lipoprotein level will be measured by IMMULITE 1000 (Siemens,Germany).
Time Frame
4 weeks and 12 weeks
Title
Fast high density lipoprotein level
Description
The fast high density lipoprotein level will be measured by IMMULITE 1000 (Siemens,Germany).
Time Frame
4 weeks and 12 weeks
Title
Defecation status
Description
Care givers describe the defecation status in the past 1 week, including the frequency, nature, and color.
Time Frame
4 weeks and 12 weeks
Title
Abdominal pain
Description
Care givers describe whether abdominal pain occurs, and if so, provide frequency.
Time Frame
4 weeks and 12 weeks
Title
Excessive flatulence
Description
Care givers describe whether excessive flatulence occurs, and if so, provide frequency.
Time Frame
4 weeks and 12 weeks
Title
Fast insulin level
Description
The fast insulin level will be measured by IMMULITE 1000 (Siemens,Germany).
Time Frame
4 weeks and 12 weeks
Title
Fast glucose level
Description
The fast glucose level is detected by fingertip blood with blood glucose meter.
Time Frame
4 weeks and 12 weeks
Title
Body mass index
Description
Body mass index is calculated as weight (kg)/[Height (m)^2]. Weight and height will be combined to report BMI in kg/m^2.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Lu, Dr
Phone
86-021-64933281
Email
wei_lu@fudan.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Lu, Dr
Organizational Affiliation
Children's Hospitial of Fudan Univeristy
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Lui
Phone
86-021-64933281
Email
wei_lu@fudan.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
After applying to the researcher, the researcher will decide whether to share the data

Learn more about this trial

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

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