Randomised Placebo Controlled Trial of Faecal Microbiota Transplantation in Irritable Bowel Syndrome
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- University College Cork
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Global Assessment of relief of IBS symptoms.
Study Overview
Brief Summary
The purpose of thus study is to determine if faecal microbiota transplantation will result in improvement in clinical outcomes in patients with irritable bowel syndrome.
Detailed Description
- Background
Irritable bowel syndrome (IBS) is a chronic, debilitating, functional gastrointestinal disorder with estimated population prevalence in Europe between of 10 -15% (Ford et al). These symptoms can be debilitating and lead to a significant reduction in quality of life particularly in the more severely affected.
Alterations in the function and composition of the gut microbiota are increasingly being implicated as potential aetiological factors. (Collins et al). One of the strongest indictors for this concept is the significantly increased risk of developing IBS after an episode of acute gastroenteritis. Prospective studies have demonstrated that between 3- 36% of enteric infections lead to new, persistent IBS symptoms. (Gwee at al.,Neal et al) A number of studies have demonstrated that the diversity, stability and metabolic activity of the gut microbiota are altered in IBS patients compared with healthy individuals (Jeffrey et al). Although a distinct microbial signature has not been identified for IBS, several studies have shown a gut microbial composition enriched with Firmicutes together with a reduced abundance of Bacteroides (Jeffery et al, Rajilic-Stojanovic et al).
Faecal microbial transplantation (FMT) has proven to a safe, inexpensive and effective treatment for recurrent Clostridium difficile infection achieving up to 90% cure rates in some studies with a very good side effect and adverse event profile (van. Nood et al.). In this study the investigators wish to investigate whether restoring healthy gut microbiota profiles, using stool from healthy donors, will lead to improved clinical outcomes for patients with IBS.
Autologous fecal microbiota transplant using re - infusion of the participants own faeces has been previously been used as a placebo in studies using FMT (Vrieze et al) 2. Study Design
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •To be considered eligible for enrolment into the study, subjects must;
- •Be able to give written informed consent.
- •Males and females aged >18 and <65
- •Have IBS as defined by the Rome III criteria
Exclusion Criteria
- •Subjects will be excluded from the study if they meet any of the below criteria;
- •Are less than 18 and greater than 65 years of age.
- •Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal, endocrine, immunological, metabolic or any condition which contraindicates, in the investigators' judgment, entry to the study).
- •Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial.
- •Are receiving treatment involving experimental drugs.
- •If the subject has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study.
- •Have a malignant disease or any concomitant end-stage organ disease Pregnancy
- •Use of antibiotics within 6 weeks of screening.
- •Use of systemic steroids within the last month.
- •Use of an antipsychotic within prior 3 months.
- •Have suffered from a major psychiatric disorder with the past two years.
- •Lactose intolerance.
- •Those > 55 will be excluded if they have not had a sigmoidoscopy or colonoscopy within previous 5 years.
- •Any abdominal surgery other than hernia repair or appendicectomy.
Outcomes
Primary Outcomes
Global Assessment of relief of IBS symptoms.
Time Frame: 8 weeks
This assessment will be obtained by defining the response (Yes or No) to the following question. "Please consider how you felt in the past week in regard to your IBS, in particular your overall well-being, and symptoms of abdominal discomfort or pain, bloating or distension and altered bowel habit .Compared to the way you usually felt before the beginning of the trial, have you had adequate relief of your IBS-symptoms?"
Secondary Outcomes
- Quality of life(8 weeks)
- Primary symptoms of IBS(8 weeks)
- Safety as measured by occurrence of adverse events(8 weeks)
- Depression and Anxiety(8 weeks)
Investigators
Professor Fergus Shanahan
Professor and Chair Department of Medicine and Director Alimentary Pharmabiotic Centre, University College Cork
University College Cork