Faecal Microbiota Transplantation in Irritable Bowel Syndrome
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|ClinicalTrials.gov Identifier: NCT02423421|
Recruitment Status : Unknown
Verified April 2015 by Professor Fergus Shanahan, University College Cork.
Recruitment status was: Recruiting
First Posted : April 22, 2015
Last Update Posted : April 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome||Other: Faecal microbiota transplantation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Randomised Placebo Controlled Trial of Faecal Microbiota Transplantation in Irritable Bowel Syndrome|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||June 2016|
Active Comparator: Treatment group
The treatment group will have faecal microbiota transplantation performed using stool from a healthy human donor
Other: Faecal microbiota transplantation
Placebo Comparator: Placebo group
The placebo group will have autologous faecal microbiota transplantation performed.
Other: Faecal microbiota transplantation
- 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?"
- 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
- 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.
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
|Contact: Donal Sheehan, MB BAO BCHfirstname.lastname@example.org|
|Contact: Susan Rafferty - McArdle, PhD||+353 21 email@example.com|
|Alimentary Pharmabiotic Centre, University College Cork||Recruiting|
|Contact: Susan Rafferty - McArdle, PHD +353 21 4901753 firstname.lastname@example.org|
|Principal Investigator:||Fergus Shanahan, MD, DSc||Professor and Chair Dept. of Medicine, University College Cork|