Overview

This trial is active, not recruiting.

Condition irritable bowel syndrome (ibs)
Treatment fecal transplantation
Sponsor Örebro University, Sweden
Start date September 2013
End date December 2016
Trial size 17 participants
Trial identifier NCT02092402, 2013/180

Summary

The purpose of this study is to investigate the effect of fecal microbiota transplantation (FMT) on the symptoms of irritable bowel syndrome (IBS) patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Autologous fecal transplantation (own stool)
fecal transplantation
(Experimental)
Allogeneic fecal transplantation (from donor)
fecal transplantation

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Effect of fecal transplantation on IBS patients' visceral perception (Pain scores on the visual analogue scale during barostat procedure)
time frame: 2 months
Effect of fecal transplantation on IBS patients' composition of mucosal microbiota (HITChip analysis)
time frame: 2 months
Effect of fecal transplantation on IBS patients' composition of fecal microbiota (HITChip analysis)
time frame: 6 months
Effect of fecal transplantation on IBS patients' mucosal immune cell composition (lymphocyte fingerprinting using flow cytometry)
time frame: 2 months
Effect of fecal microbiota transplantation on the symptoms of IBS patients using the IBS - severity scoring system (IBS-SSS)
time frame: 6 months
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
Effect of fecal microbiota transplantation on the symptoms of IBS patients using the hospital and anxiety depression scale (HADS)
time frame: 6 months
Effect of fecal microbiota transplantation on the general health of IBS patients using the SF-36 survey
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion criteria for patients 1. Signed informed consent 2. 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 3. Age: 18-65 years Exclusion criteria for patients 1. High proportion of butyrate-producing microbiota in fecal samples 2. Known organic gastrointestinal disease (e.g. IBD) 3. Previous complicated gastrointestinal surgery 4. Non-gastrointestinal malignancy 5. Dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation 6. Females who are pregnant or breast-feeding 7. Severe endometriosis 8. Antimicrobial treatment 4 weeks prior to first screening visit 9. Antimicrobial prophylaxis (eg. acne, urinary tract infection) 10. Regular consumption of probiotic products 4 weeks prior to randomization 11. Recently (within the last 3 months) diagnosed lactose intolerance 12. Celiac disease 13. Abuse of alcohol or drugs 14. Any clinically significant disease/condition which in the investigator's opinion could interfere with the results of the trial Inclusion criteria for donors 1. Signed informed consent 2. High-butyrate producing microbiota in fecal samples 3. Age: 18-65 years Exclusion criteria for donors 1. Known organic gastrointestinal disease (e.g. IBD, IBS, chronic diarrhea or constipation) 2. Gastrointestinal malignancy or polyposis 3. History of major gastrointestinal surgery (e.g. gastric bypass) 4. Eosinophilic disorders of the gastrointestinal tract 5. Current communicable disease (e.g. upper respiratory tract infection) 6. Known or high risk of infectious diseases such as HIV, hepatitis A, B or C 7. Non-gastrointestinal malignancy 8. Dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation 9. Comorbidities such as metabolic syndrome, autoimmune diseases, allergies 10. Chronic pain syndromes (eg. chronic fatigue syndrome, fibromyalgia) 11. Severe or morbid obesity 12. Use of immunosuppressive or chemotherapy agents 13. Antimicrobial treatment or prophylaxis within the last 6 months 14. Females who are pregnant or breast-feeding 15. Known clinically significant abnormal laboratory values 16. Participation in high-risk sexual behaviors 17. Abuse of alcohol or drugs 18. Tattoo or body piercing within the last 6 months 19. Travel to areas with endemic diarrhea during the last 3 months 20. Positive stool testing for C. difficile toxin, ova, parasites, Giarda antigen, cryptosporidium antigen

Additional Information

Official title Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome
Principal investigator Robert J Brummer, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Örebro University, Sweden.