Faecal Microbiota Transplantation in Irritable Bowel Syndrome: a Randomised, Double-blind Cross-over Study Utilising Mixed Microbiota From Healthy Donors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Change in the IBS severity symptom score (IBS-SSS)
研究概览
简要总结
Irritable bowel syndrome (IBS) is the most common functional bowel disorder, being present in approximately 10% of adult Europoid population. The etiology of IBS is elusive. Literature indicates that modification of patients´colonic microbiota might ameliorate the condition. Here we test an intervention by faecal microbiota transplantation of artificially inflated microbiome diversity, versus autoclaved placebo.
详细描述
Three-groups, double-blind, placebo-controlled, randomised, cross-over study in adult patients diagnosed with IBS (diarrhoeal or mixed form) according to Rome IV criteria. Each study subject will undergo two pairs of faecal microbiota transplantation (a total of four enemas for each patient), with the pairs of transfers being eight weeks apart. The active intervention substance is a mixed stool microbiota derived from healthy individuals, screened for infectious diseases according to European consensus conference on faecal microbiota transplantation guidelines, and who were preselected for high alpha diversity of their microbiome and distance in community ordination from IBS patients microbiota. Placebo is the same mixture, inactivated by autoclaving.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
double-blind
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
- 否
入选标准
- •Diarrhea Predominant Irritable Bowel Syndrome (IBS-D) or Irritable Bowel Syndrome with mixed bowel habits (IBS-M) according to the Rome IV criteria
排除标准
- •The use of antibiotics within one month prior to faecal microbiota transplantation
- •The use of probiotics within one month prior to faecal microbiota transplantation
- •History of inflammatory bowel disease or gastrointestinal malignancy, systemic autoimmune diseases (ongoing or in history)
- •Previous abdominal surgery (other than appendectomy or cholecystectomy or hernioplasty or cesarean section)
- •HIV infection or other active infection
- •Renal or hepatic disease (both defined by biochemistry workup)
- •Diabetes mellitus, abnormal thyroid functions not controlled by thyroid medications
- •Bipolar disorder or schizophrenia (ongoing or history thereof), moderately severe depression defined by Patient Health Questionnaire-9 (PHQ-9) score > 15
- •Anxiety defined by a Generalised Anxiety Disorder 7 (GAD7) score > 10
- •Current pregnancy and lactation
结局指标
主要结局
Change in the IBS severity symptom score (IBS-SSS)
时间窗: The difference between the score at four weeks after the intervention (study weeks 5 or 13, respectively) and the baseline score (week -1 in 'Active microbiota first' group or week 8 in 'Inactive microbiota first' group)
Change in the IBS severity symptom score (IBS-SSS) in the active microbiota group relative to the placebo group.
次要结局
- The acute change in the IBS severity symptom score (IBS-SSS)(study weeks 3 and 11, respectively)
- Change in number of loose stools per day(baseline and study week 32)
- Change in abdominal pain(baseline and study week 32)
- Change in waist circumference(baseline and study week 32)
- Change in Body Mass Index(baseline and study week 32)
- Change in the quantity of single-cell protist Blastocystis(baseline and study week 32)
- Change in body fat mass measured by bioelectrical impedance analysis(baseline and study week 32)
- Change in faecal microbiome's beta (between samples) diversity(baseline and study week 32)
- The psychological and well-being effects of the therapy (IBS-QoL)(baseline and study week 32)
- The long-term change in the IBS severity symptom score (IBS-SSS)(baseline and study week 32)
- Change in stool consistency(baseline and study week 32)
- Change in frequency of bloating per week(baseline and study week 32)
- Change in body fat mass estimated by skinfold thickness measuring(baseline and study week 32)
- Change in faecal microbiome's alpha (within-sample) diversity(baseline and study week 32)
研究者
Pavel Kohout
Pavel Kohout, Assoc. Prof., MD, PhD.
Thomayer University Hospital