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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics group | Experimental | Take probiotics during the study |
|
| Probiotics and prebiotics group | Experimental | Take probiotics and prebiotics during the study |
|
| Control group | No Intervention | Take placebo food during the study |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| probiotics including B. lactis B420, B. lactis HN019, B. animalis Bb-12, L. rhamnosus GG | Dietary Supplement | Take probiotics, 2g each time, twice a day, for 12 weeks |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Lu, Dr | Contact | 86-021-64933281 | wei_lu@fudan.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Wei Lu, Dr | Children's Hospitial of Fudan Univeristy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | China |
After applying to the researcher, the researcher will decide whether to share the data
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 5, 2023 |
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| Prebiotics with galactomannan and oligofructose | Dietary Supplement | Take probiotics, 2g each time, twice a day, for 12 weeks Take prebiotics, 25g each time, twice a day, for 12 weeks |
|
| 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 |
| Mar 17, 2023 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D011218 | Prader-Willi Syndrome |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D000096803 | Imprinting Disorders |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D056692 | Prebiotics |
| C012990 | galactomannan |
| C120489 | oligofructose |
| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
| D011134 | Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019587 | Dietary Supplements |
| D019602 | Food and Beverages |
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