Effect of Fecal Microbiota Transplantation in Irritable Bowel Syndrome (IBS) - a Randomized, Double-blind Placebo Controlled Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- symptoms score
研究概览
简要总结
The purpose of this study is to investigate if fecal microbiota transplantation (FMT) will result in improvement in clinical outcome in patients with irritable bowel syndrome (IBS).
详细描述
Irritable bowel syndrome (IBS) is the most commonly diagnosed gastrointestinal condition. IBS is associated with a high use of health-care costs and can substantially reduce quality of life and work productivity.
Several studies have demonstrated that the composition of the gut microbiota in IBS patients is different from healthy controls.
Fecal microbiota transplantation (FMT) could therefore be a treatment option for IBS patients by exchanging the microbiota of an IBS patient with the microbiota of a healthy donor.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfilled Rome III diagnostic criteria for IBS
- •Moderate-severe disease activity (IBS-Symptom Severity Score ≥175)
- •Able to read and speak Danish
- •Normal colonoscopy at age ≥ 40 years (performed within 1 year) or blood in stool
排除标准
- •Other chronic gastrointestinal disease
- •Positive fecal sample with enteropathogenic microorganisms or Clostridium difficile
- •Positive screening for HIV, Hepatitis B or HCV antibody
- •Surgical interventions in the gastrointestinal region (except for appendectomy, hernia repair, cholecystectomy, and gynecological and urological procedures)
- •Psychiatric disorder
- •Fecal calprotectin ≥ 50 mg/kg
- •Abuse of alcohol or drugs
- •Medications other than birth control pills, hormone supplements, allergies and asthma agents, blood pressure and cholesterol lowering agents, proton pump inhibitors and non-prescription medicines
- •Abnormal screening biochemistry
- •Abnormal colonoscopy findings
- •Pregnant, planned pregnancy or breastfeeding females
- •Ingestion of probiotics or antibiotics < 8 weeks before the inclusion
- •Inclusion criteria for donors
- •Age between 18-45 years
- •Past and current healthy
- •Normal weight (BMI between 18,5-24,9 kg/m2)
- •Normal bowel movements (defined as 1-2 per day and type 3-4 at Bristol Stool Form Scale)
- •No medication consumption
- •Exclusion criteria for donors
- •Known or high risk of infectious diseases such as HIV, hepatitis A, B or C
- •Positive stool sample for C. difficile toxin, parasites or other pathogens
- •Antibiotic treatment in the past 6 months
- •Abuse of alcohol or drugs
- •Tattoo or body piercing within the last 6 months
- •Allergy, asthma or eczema
- •Family history of gastrointestinal diseases
- •Participation in high-risk sexual behaviors
- •Born by Caesarean section
研究组 & 干预措施
FMT placebo
Placebo capsules
干预措施: FMT placebo (Dietary Supplement)
FMT capsules
FMT capsules
干预措施: FMT capsules (Dietary Supplement)
结局指标
主要结局
symptoms score
时间窗: 12 weeks
Measured by the Irritable bowel syndrome - severity symptom score (IBS-SSS)
次要结局
- Change in microbiota diversity(Day 4, 4 weeks, 12 weeks and 24 weeks)
- Microbiota diversity IBS patients(Baseline)
- Microbiota diversity in healthy donors(Baseline)
- Change in Irritable Bowel Syndrome-Quality of Life (IBS-QOL) Questionnaire Scores(Baseline, 4 weeks, 12 weeks and 24 weeks)
研究者
Alice Højer Christensen
MD, PhD
Aleris-Hamlet Hospitaler København