The Role of Microbiome in Recurrent Obesity Before and After Antibiotic/Placebo Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- microbiome composition
研究概览
简要总结
This past century witnessed a significant increase in the prevalence of obesity. Successful weight loss maintenance is defined as losing at least 10% of the initial body weight and maintaining it for at least one year. However, keeping a low body weight is rarely maintained, as 80% of people who lost 10% of their body weight will return to their initial weight within a year. Although there is no agreement as to what contributes to the recurrent weight regain phenomenon (also known as 'weight cycling' or 'yo-yo diet'), it is strongly associated with the risk of developing metabolic risk factors and their complications, including heart disease and all-cause mortality. Altering the gut microbiota is one method to treat disease states associated with gut bacteria. Antibiotics consumption is known to influence host glycemic response through changes induced in microbiome composition and function. Therefore, it may be a possible pathway to jumpstart changes in the gut microbiota.
This study will determine whether microbiome modulation might be a possible future target against recurrent obesity in humans and whether orally administered antibiotic treatment post-weight loss might be an effective intervention to prevent weight regain.
详细描述
This is a placebo-controlled, double blinded interventional study evaluating the effect of antibiotic treatment in the prevention of weight regain after a successful weight loss intervention.
Volunteers will be recruited in the following ways: e-mail, and social media. Volunteers wishing to participate will be asked to complete a questionnaire regarding the aforementioned inclusion and exclusion criteria. Volunteers who qualify for the study will be invited to an introductory meeting at the Weizmann Institute of Science. The details of the experiment and potential risks or discomforts involved in it will be presented, after which the volunteers will sign an informed consent form. Volunteers will start the study and become active participants for a maximal duration of one year.
Samples collected for the study will be used for microbiota profiling (stool and oral), metabolomics (stool, blood) and for bomb calorimeter (stool).
The study will comprise of four parts:
- Baseline - one week of profiling and screening.
- Nutritional intervention - weight loss intervention which will be based on personalized hypocaloric diet restriction. Meetings will occur twice a month starting from the second week of the study for a three-month period.
- Antibiotic treatment - 10 days of either antibiotics- Augmentin (amoxicillin+clauvonate), 875mg, 2 /day, or 10 days of placebo pills, 2/day.
- Follow-up meetings - total follow up of 9 months after antibiotic/placebo treatment. Meetings will occur once a month for the first 3 months of the follow up period, and once every 3 months, afterwards.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •28 < BMI< 40
- •Age - 18-65
- •Capable of working with a smartphone application
排除标准
- •Consumption of antibiotics/probiotics/oral antifungals 2 months prior to the first day of the experiment.
- •Pregnancy, fertility treatments, breastfeeding women six months prior to enrollment and during the study.
- •Chronic disease, to the discretion of the study team (e.g. AIDS, Cushing syndrome, CKD, acromegaly etc.)
- •Cancer and recent anticancer treatment
- •Psychiatric disorders, to the discretion of the study team.
- •Coagulation disorders
- •IBD (inflammatory bowel diseases)
- •Bariatric surgery.
- •Eating disorders (Anorexia nervosa. Bulimia nervosa. Binge eating disorder, Night eating syndrome).
- •Alcohol or substance abuse
- •Weight loss attempts 6 months prior to the first day of the experiment - using weight loss medication.
- •Drastic changes in nutritional habits six months prior to the first day of the study - to the discretion of the study team.
- •Allergy to penicillin.
- •Life threatening reaction after consumption of cephalosporins.
- •History of CDI
- •Liver disease
- •History of serious unresolved diarrhea in response to antibiotic treatment to the discretion of the study doctor.
研究组 & 干预措施
Antibiotic treatment
intervention arm
干预措施: Antibiotic treatment (Other)
Placebo
placebo capsules administration
干预措施: Placebo (Other)
结局指标
主要结局
microbiome composition
时间窗: 1 year
using stool and oral samples
weight
时间窗: 1 year
weight (kg)
次要结局
- glycemic response(1 year)