Irritable Bowel Syndrome (IBS) | Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS) research study
What is the primary objective of this study?
The purpose of this study is to investigate the effect of fecal microbiota transplantation (FMT) on the symptoms of irritable bowel syndrome (IBS) patients.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Irritable Bowel Syndrome (IBS)
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Fecal transplantation of own stoolAutologous fecal transplantation (own stool)
Fecal transplantation (stool from donor)Allogeneic fecal transplantation (from donor)
Start Date: September 2013
Completed Date: June 2019
Primary Outcome: Effect of fecal microbiota transplantation on the symptoms of IBS patients using the IBS version of the gastrointestinal symptom rating scale (GSRS-IBS)
Secondary Outcome: Effect of fecal transplantation on IBS patients' visceral perception (Pain scores on the visual analogue scale during barostat procedure)
Study sponsors, principal investigator, and references
Principal Investigator: Robert J Brummer, MD, PhD
Lead Sponsor: Örebro University, Sweden