Fecal Microbiota Transplantation for the Treatment of Obesity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Adverse Event Frequency
研究概览
简要总结
This is a randomized controlled pilot study to assess the microbiological and clinical impacts of Fecal Microbiota Transplantation (FMT) in patients with obesity. The investigators will prospectively enroll 20 adult patients who are obese (Body Mass Index of 35kg/m2 or higher) after providing written informed consent. The study participants will be randomized 1:1 to either the treatment arm or the placebo arm. The treatment arm will receive an induction FMT with capsules followed by a monthly maintenance dose of oral capsules for 12 weeks total. The placebo group will receive a placebo capsules for induction followed by monthly intake of oral placebo capsules for 12 weeks.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Obesity defined as a BMI of 35kg/m2 or higher
排除标准
- •Triglycerides > 500 mg/dL
- •Use of antibiotics <8 weeks prior to participation
- •Use of probiotics <4 weeks prior to participation
- •Alcohol use of greater than 20g/daily or suspicion of alcohol abuse and dependence
- •Substance abuse, current
- •LFTS greater then 3x the ULN
- •DM type 2 that is insulin dependent, treated with GLP1-agonists, or poorly controlled on oral medications (HbA1C > 10%)
- •Use of any weight loss medication or participation in a weight loss study or program such as Weight Watchers
- •History of recent weight change (weight loss or weight gain in the two months preceding trial enrollment). This is defined as a gain or loss of 10 or more pounds in the preceding 2 months
- •Patients who are pregnant or breastfeeding
- •Patients who are unable to give informed consent
- •Patients who have previously undergone FMT
- •Patients who have a confirmed malignancy or cancer
- •Patients who are immunocompromised
- •Participation in a clinical trial in the preceding 30 days or simultaneously during this trial
- •Previous gastric or small intestinal surgery that alters gut anatomy such as fundoplication, gastric resection, gastric bypass, small bowel resection, and ileocectomy
- •Other comorbidities including: systemic lupus, inflammatory bowel disease, or Chronic kidney disease as defined by a GFR <60mL/min/1.73m2 44
- •History of rheumatic heart disease, endocarditis, or valvular disease due to risk of bacteremia
- •Any condition, based on clinical judgment that may make study participation unsafe
- •History of severe food allergies
- •Use of immune modulators including methotrexate, mycophenolate mofetil, tacrolimus, cyclosporine, thalidomide, Interleukin-10, or Interleukin-11 24.Treatment with infliximab, adalimumab, certolizumab, natalizumab, vedolizumab or thalidomide
- •Congenital or acquired immunodeficiencies
结局指标
主要结局
Adverse Event Frequency
时间窗: 6 months
Number of patients reporting adverse events
次要结局
- Assess Change of AUC of GLP-1 as a Therapeutic Biomarker for Clinical Response to Fecal Microbiota Transplantation From Baseline to Week 12(12 weeks)
研究者
Christopher C. Thompson, MD, MSc
Attending Physician
Brigham and Women's Hospital