About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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);
Trial design
Parallel
Treatments tested in this trial
probiotics including B. lactis B420, B. lactis HN019, B. animalis Bb-12, L. rhamnosus GG
Dietary supplementTake probiotics, 2g each time, twice a day, for 12 weeks
Prebiotics with galactomannan and oligofructose
Dietary supplementTake probiotics, 2g each time, twice a day, for 12 weeks Take prebiotics, 25g each time, twice a day, for 12 weeks
Treatment groups
Trial outcomes
Primary outcomes
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 outcomes
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.
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