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临床试验/NCT05874830
NCT05874830招募中不适用

The Optimal Route of Fecal Microbiota Transplantation for Irritable Bowel Syndrome

Turku University Hospital6 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
36
试验地点
6
主要终点
Efficacy of the different routes of FMT, for alteration of gut microbiota towards that of the donor.

研究概览

简要总结

The object of this study is to find out is there an optimal route for the fecal microbiata transplant (FMT) in patients that suffer from irritable bowel syndrome. The investigators compare outcomes in patients with repeated fecal microbiome samples and make symptomatic questionnaires (i.e. IBS-SSS, GSRS) to find out if there is difference in severity of symptoms compared to FMT given in duodenogastroscopy or in coloscopy.

详细描述

Irritable bowel syndrome (IBS) is a common functional disorder affecting approximately 10% globally.[1] It is often referred to as benign, although, when severe, may cause significant reduction of quality of life and work absenteeism. The etiology of IBS is unknown although many theories have been proposed. Altered gut motility, epithelial hyperpermeability, low grade inflammation, visceral hypersensitivity, epigenetics and genetics, altered gut-brain interaction and psychological stressors have all been reported in patients with IBS.

Several studies have detected alterations in the gut microbiota composition between IBS patients and healthy controls, however a microbiota typical for IBS patients has not been conclusively defined.

Fecal microbiota transplantation has over 90% efficace in recurrent Clostridioides difficile infection (rCDI), for which it has been in clinical use for a decade. FMT is currently recommended after the second relapse of rCDI. FMT is recommended to be considered only in clinical trial settings for other indications than rCDI.

Randomized controlled studies in FMT for IBS have conflicting results. In studies with a single administration of FMT in colonoscopy a mild transient reduction of IBS symptoms has followed the intervention. In studies with fecal capsules there has not been any benefit observed. FMT via gastroscopy exerted a clear benefit with an up to 89.1% response rate. These surprisingly good results were thought to be contributable to careful donor selection, however the study included only one donor and no specific characteristics of microbiota were indentified of the suspected superdonor. Although all these three administration routes altered the microbiota of IBS patients towards that of the donor, a concurrent decrease in the symptoms was observed only when FMT was administered via colonoscopy or gastroscopy.

Manipulation of microbiota through FMT remains to be potential treatment option for IBS, however, several mechanistic questions await answering. Investigators do not yet know what is the component of stool which would carry the healing potential. There needs to be further research to define optimal donors as well as optimal patients who would be prone to benefit of FMT. The amount and number of FMT treatments may be a factor contributing to the outcome.

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, Care Provider, Investigator)

盲法说明

The patient and the endoscopists are blinded when the FMT/plasebo is given

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-70 years
  • known of Finnish language
  • IBS, (new or old diagnosis according to Roma III or IV criteria), all subtypes
  • Informed consent
  • Moderate to severe IBS symptoms, IBS-SSS > 175

排除标准

  • Pregnancy
  • Antibiotic or probiotic treatment, on-going or previous month
  • Abuse of drugs, alcohol or medications
  • Other diagnosis besides IBS causing the GI symptoms, such as IBD, microscopic colitis or bile acid diarrhea

结局指标

主要结局

Efficacy of the different routes of FMT, for alteration of gut microbiota towards that of the donor.

时间窗: Microbiota is tested at prescreening visit, at the baseline and in 4, 12 and 52 weeks after FMT-procedure.

The changes in the engraftment of specific bacteria between the active groups is of special interest, and the changes in the microbiota during the whole of study in the intervention group and in the plasebo group.

次要结局

  • Mood, General Anxiety-Disorder 7 - questionnaire(The change in the score of questionnaires between the baseline at 3 months and 12 months)
  • The main clinical outcome is reduction of abdominal pain three months after FMT.(3 months)
  • GI Symptoms: THE GASTROINTESTINAL SYMPTOM RATING SCALE (GSRS)(in 3 months and in 1 year points compared to baseline.)
  • Mood, Beck's Depression Inventory.(The change in the score of questionnaires between the baseline at 3 months and 12 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Kimmo Salminen

MD, Specialist in Gastroenterology and Geriatrics

Turku University Hospital

研究点 (6)

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