Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Örebro University, Sweden
Sponsor:
Information provided by (Responsible Party):
Robert Brummer, Örebro University, Sweden
ClinicalTrials.gov Identifier:
NCT02092402
First received: March 17, 2014
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Irritable Bowel Syndrome (IBS)
Other: Fecal transplantation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome

Resource links provided by NLM:


Further study details as provided by Örebro University, Sweden:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of fecal transplantation on IBS patients' visceral perception (Pain scores on the visual analogue scale during barostat procedure) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Effect of fecal transplantation on IBS patients' composition of mucosal microbiota (HITChip analysis) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Effect of fecal transplantation on IBS patients' composition of fecal microbiota (HITChip analysis) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Effect of fecal transplantation on IBS patients' mucosal immune cell composition (lymphocyte fingerprinting using flow cytometry) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Effect of fecal microbiota transplantation on the symptoms of IBS patients using the IBS - severity scoring system (IBS-SSS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Effect of fecal microbiota transplantation on the symptoms of IBS patients using the hospital and anxiety depression scale (HADS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Effect of fecal microbiota transplantation on the general health of IBS patients using the SF-36 survey [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: September 2013
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Fecal transplantation of own stool
Autologous fecal transplantation (own stool)
Other: Fecal transplantation
Experimental: Fecal transplantation (stool from donor)
Allogeneic fecal transplantation (from donor)
Other: Fecal transplantation

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02092402

Contacts
Contact: Robert J Brummer, MD, PhD +46 19 30 37 31 robert.brummer@oru.se
Contact: Julia König, PhD +46 19 30 36 45 julia.konig@oru.se

Locations
Sweden
University Hospital Örebro Recruiting
Örebro, Sweden, 70185
Contact: Robert J Brummer, MD, PhD    +46 19 30 37 31    robert.brummer@oru.se   
Contact: Julia König, PhD    +46 19 30 36 45    julia.konig@oru.se   
Principal Investigator: Robert J Brummer, MD, PhD         
Sub-Investigator: Julia König, PhD         
Sponsors and Collaborators
Örebro University, Sweden
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
  More Information

No publications provided

Responsible Party: Robert Brummer, MD, PhD, Örebro University, Sweden
ClinicalTrials.gov Identifier: NCT02092402     History of Changes
Other Study ID Numbers: 2013/180
Study First Received: March 17, 2014
Last Updated: March 20, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Örebro University, Sweden:
Fecal transplantation
microbiota transplantation
irritable bowel syndrome
IBS

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

ClinicalTrials.gov processed this record on September 11, 2014