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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prader-Willi Syndrome

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics group<br>Take probiotics during the study | Dietary Supplement: probiotics including B. lactis B420, B. lactis HN019, B. animalis Bb-12, L. rhamnosus GG<br>* Take probiotics, 2g each time, twice a day, for 12 weeks<br>|
| Experimental: Probiotics and prebiotics group<br>Take probiotics and prebiotics during the study | Dietary Supplement: probiotics including B. lactis B420, B. lactis HN019, B. animalis Bb-12, L. rhamnosus GG<br>* Take probiotics, 2g each time, twice a day, for 12 weeks<br>Dietary Supplement: Prebiotics with galactomannan and oligofructose<br>* Take probiotics, 2g each time, twice a day, for 12 weeks Take prebiotics, 25g each time, twice a day, for 12 weeks<br>|
| No Intervention: Control group<br>Take placebo food during the study | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prader-Willi syndrome, Probiotics, Prebiotics