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Faecal Microbiota Transplantation in Irritable Bowel Syndrome

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2015 by Professor Fergus Shanahan, University College Cork.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02423421
First Posted: April 22, 2015
Last Update Posted: April 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Professor Fergus Shanahan, University College Cork
  Purpose
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.

Condition Intervention Phase
Irritable Bowel Syndrome Other: Faecal microbiota transplantation Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Placebo Controlled Trial of Faecal Microbiota Transplantation in Irritable Bowel Syndrome

Resource links provided by NLM:


Further study details as provided by Professor Fergus Shanahan, University College Cork:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Primary symptoms of IBS [ Time Frame: 8 weeks ]
    The primary symptoms of IBS will be scored on a six point Likert scale at baseline, week 4 and at end of study. The following symptoms will be assessed and recorded: abdominal pain/discomfort, bloating/distension, sense of incomplete evacuation, straining at stool, urgency of bowel movement, passage of gas and mucus, bowel habit satisfaction. Each symptom will be assessed using a 6-point scale, where 0 = none to 5 = very severe. Bowel habit satisfaction will be assessed using a 6-point scale where 0 = very satisfied and 5 = very dissatisfied. Overall assessment of IBS symptoms will be also be scored on a 6 - point scale. An IBS composite score(15 point score) representing the sum of individual scores for abdominal pain/discomfort, bloating/distension, and bowel movement difficulty (straining at stool or urgency of bowel movement) will be calculated.

  • Quality of life [ Time Frame: 8 weeks ]
    At baseline and at the end of the study each subject will complete an IBS-specific quality of life questionnaire (IBS-QOL)

  • Depression and Anxiety [ Time Frame: 8 weeks ]
    At baseline and at the end of the study each subject will complete the Hospital Anxiety and Depression (HAD) Scale.

  • Safety as measured by occurrence of adverse events [ Time Frame: 8 weeks ]
    Patients will be monitored throughout the study period and they will be recorded as per the The Consolidated Standards of Reporting Trials (CONSORT) criteria


Other Outcome Measures:
  • Patient microbiota compositional profiles [ Time Frame: 8 weeks ]
    We will characterise all participants' microbiota composition at baseline and at the end of study to determine if there is a subgroup of patient/donor combinations, based on their microbiota composition, in whom a positive response to FMT was obtained. This would be very valuable for future optimization of a positive primary outcome.


Estimated Enrollment: 50
Study Start Date: March 2015
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment group
The treatment group will have faecal microbiota transplantation performed using stool from a healthy human donor
Other: Faecal microbiota transplantation
Human Stool.
Placebo Comparator: Placebo group
The placebo group will have autologous faecal microbiota transplantation performed.
Other: Faecal microbiota transplantation
Human Stool.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02423421


Contacts
Contact: Donal Sheehan, MB BAO BCH donal.sheehan@ucc.ie
Contact: Susan Rafferty - McArdle, PhD +353 21 4901753 s.rafferty@ucc.ie

Locations
Ireland
Alimentary Pharmabiotic Centre, University College Cork Recruiting
Cork, Ireland
Contact: Susan Rafferty - McArdle, PHD    +353 21 4901753    s.rafferty@ucc.ie   
Sponsors and Collaborators
University College Cork
Investigators
Principal Investigator: Fergus Shanahan, MD, DSc Professor and Chair Dept. of Medicine, University College Cork
  More Information

Publications:

Responsible Party: Professor Fergus Shanahan, Professor and Chair Department of Medicine and Director Alimentary Pharmabiotic Centre, University College Cork, University College Cork
ClinicalTrials.gov Identifier: NCT02423421     History of Changes
Other Study ID Numbers: APC053
First Submitted: March 10, 2015
First Posted: April 22, 2015
Last Update Posted: April 22, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases