- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02092402
Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome
August 27, 2019 updated by: Robert Brummer, Örebro University, Sweden
The purpose of this study is to investigate the effect of fecal microbiota transplantation (FMT) on the symptoms of irritable bowel syndrome (IBS) patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Örebro, Sweden, 70185
- University hospital Örebro
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria 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
Exclusion criteria 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Fecal transplantation of own stool
Autologous fecal transplantation (own stool)
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Experimental: Fecal transplantation (stool from donor)
Allogeneic fecal transplantation (from donor)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Effect of fecal microbiota transplantation on the symptoms of IBS patients using the IBS version of the gastrointestinal symptom rating scale (GSRS-IBS)
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Effect of fecal transplantation on IBS patients' visceral perception (Pain scores on the visual analogue scale during barostat procedure)
Time Frame: 2 months
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2 months
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Effect of fecal transplantation on IBS patients' composition of mucosal microbiota (HITChip analysis)
Time Frame: 2 months
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2 months
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Effect of fecal transplantation on IBS patients' composition of fecal microbiota (HITChip analysis)
Time Frame: 6 months
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6 months
|
Effect of fecal transplantation on IBS patients' mucosal immune cell composition (lymphocyte fingerprinting using flow cytometry)
Time Frame: 2 months
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2 months
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Effect of fecal microbiota transplantation on the symptoms of IBS patients using the IBS - severity scoring system (IBS-SSS)
Time Frame: 6 months
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6 months
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Effect of fecal microbiota transplantation on the symptoms of IBS patients using the health-related quality of life questionnaire for IBS patients (IBS-QOL)
Time Frame: 6 months
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6 months
|
Effect of fecal microbiota transplantation on the symptoms of IBS patients using the hospital and anxiety depression scale (HADS)
Time Frame: 6 months
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6 months
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Effect of fecal microbiota transplantation on the general health of IBS patients using the SF-36 survey
Time Frame: 6 months
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6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert J Brummer, MD, PhD, University Hospital Örebro, Department of Gastroenterology and Örebro University, School of Health and Medical Sciences, Faculty of Medicine and Health, Örebro, Sweden
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
June 1, 2019
Study Registration Dates
First Submitted
March 17, 2014
First Submitted That Met QC Criteria
March 18, 2014
First Posted (Estimate)
March 20, 2014
Study Record Updates
Last Update Posted (Actual)
August 28, 2019
Last Update Submitted That Met QC Criteria
August 27, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013/180
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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