The Safety and Effectiveness Study of Prebiotics and Probiotics in the Intervention of Obesity in Children With Prader-Willi Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Body mass index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Probiotics and prebiotics group
Take probiotics and prebiotics during the study
干预措施: Prebiotics with galactomannan and oligofructose (Dietary Supplement)
Control group
Take placebo food during the study
Probiotics group
Take probiotics during the study
干预措施: probiotics including B. lactis B420, B. lactis HN019, B. animalis Bb-12, L. rhamnosus GG (Dietary Supplement)
Probiotics and prebiotics group
Take probiotics and prebiotics during the study
干预措施: probiotics including B. lactis B420, B. lactis HN019, B. animalis Bb-12, L. rhamnosus GG (Dietary Supplement)
结局指标
主要结局
Body mass index
时间窗: 12 weeks
Body mass index is calculated as weight (kg)/\[Height (m)\^2\]. Weight and height will be combined to report BMI in kg/m\^2.
次要结局
- Excessive flatulence(4 weeks and 12 weeks)
- Body composition(4 weeks and 12 weeks)
- The structure of gut microbiota(4 weeks and 12 weeks)
- Fast total cholesterol level(4 weeks and 12 weeks)
- Weight(4 weeks and 12 weeks)
- Waist circumference(4 weeks and 12 weeks)
- Height(4 weeks and 12 weeks)
- Glycosylated hemoglobin level(4 weeks and 12 weeks)
- Fast low density lipoprotein level(4 weeks and 12 weeks)
- Fast high density lipoprotein level(4 weeks and 12 weeks)
- Fast triglyceride level(4 weeks and 12 weeks)
- Defecation status(4 weeks and 12 weeks)
- Abdominal pain(4 weeks and 12 weeks)
- Body mass index(4 weeks)
- Fast insulin level(4 weeks and 12 weeks)
- Fast glucose level(4 weeks and 12 weeks)