NCT02092402已完成不适用
Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome
Örebro University, Sweden2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2013年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Effect of fecal microbiota transplantation on the symptoms of IBS patients using the IBS version of the gastrointestinal symptom rating scale (GSRS-IBS)
研究概览
简要总结
The purpose of this study is to investigate the effect of fecal microbiota transplantation (FMT) on the symptoms of irritable bowel syndrome (IBS) patients.
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
- 否
入选标准
- •for patients
- •Signed informed consent
- •Fulfilled Rome III diagnostic criteria for IBS, and frequency of IBS pain or discomfort for at least 2 days a week in the last 12 weeks
- •Age: 18-65 years
排除标准
- •for patients
- •High proportion of butyrate-producing microbiota in fecal samples
- •Known organic gastrointestinal disease (e.g. IBD)
- •Previous complicated gastrointestinal surgery
- •Non-gastrointestinal malignancy
- •Dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation
- •Females who are pregnant or breast-feeding
- •Severe endometriosis
- •Antimicrobial treatment 4 weeks prior to first screening visit
- •Antimicrobial prophylaxis (eg. acne, urinary tract infection)
- •Regular consumption of probiotic products 4 weeks prior to randomization
- •Recently (within the last 3 months) diagnosed lactose intolerance
- •Celiac disease
- •Abuse of alcohol or drugs
- •Any clinically significant disease/condition which in the investigator's opinion could interfere with the results of the trial
- •Inclusion criteria for donors
- •Signed informed consent
- •High-butyrate producing microbiota in fecal samples
- •Age: 18-65 years
- •Exclusion criteria for donors
- •Known organic gastrointestinal disease (e.g. IBD, IBS, chronic diarrhea or constipation)
- •Gastrointestinal malignancy or polyposis
- •History of major gastrointestinal surgery (e.g. gastric bypass)
- •Eosinophilic disorders of the gastrointestinal tract
- •Current communicable disease (e.g. upper respiratory tract infection)
- •Known or high risk of infectious diseases such as HIV, hepatitis A, B or C
- •Non-gastrointestinal malignancy
- •Dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation
- •Comorbidities such as metabolic syndrome, autoimmune diseases, allergies
- •Chronic pain syndromes (eg. chronic fatigue syndrome, fibromyalgia)
- •Severe or morbid obesity
- •Use of immunosuppressive or chemotherapy agents
- •Antimicrobial treatment or prophylaxis within the last 6 months
- •Females who are pregnant or breast-feeding
- •Known clinically significant abnormal laboratory values
- •Participation in high-risk sexual behaviors
- •Abuse of alcohol or drugs
- •Tattoo or body piercing within the last 6 months
- •Travel to areas with endemic diarrhea during the last 3 months
- •Positive stool testing for C. difficile toxin, ova, parasites, Giarda antigen, cryptosporidium antigen
研究组 & 干预措施
Fecal transplantation of own stool
Placebo Comparator
Autologous fecal transplantation (own stool)
干预措施: Fecal transplantation (Other)
Fecal transplantation (stool from donor)
Experimental
Allogeneic fecal transplantation (from donor)
干预措施: Fecal transplantation (Other)
结局指标
主要结局
Effect of fecal microbiota transplantation on the symptoms of IBS patients using the IBS version of the gastrointestinal symptom rating scale (GSRS-IBS)
时间窗: 6 months
次要结局
- Effect of fecal microbiota transplantation on the symptoms of IBS patients using the IBS - severity scoring system (IBS-SSS)(6 months)
- Effect of fecal microbiota transplantation on the general health of IBS patients using the SF-36 survey(6 months)
- Effect of fecal transplantation on IBS patients' composition of mucosal microbiota (HITChip analysis)(2 months)
- Effect of fecal transplantation on IBS patients' mucosal immune cell composition (lymphocyte fingerprinting using flow cytometry)(2 months)
- Effect of fecal microbiota transplantation on the symptoms of IBS patients using the health-related quality of life questionnaire for IBS patients (IBS-QOL)(6 months)
- Effect of fecal microbiota transplantation on the symptoms of IBS patients using the hospital and anxiety depression scale (HADS)(6 months)
- Effect of fecal transplantation on IBS patients' visceral perception (Pain scores on the visual analogue scale during barostat procedure)(2 months)
- Effect of fecal transplantation on IBS patients' composition of fecal microbiota (HITChip analysis)(6 months)
研究者
Robert Brummer
MD, PhD
Örebro University, Sweden
研究点 (2)
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