Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome

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: Irritable Bowel Syndrome (IBS)
• Intervention / Treatment: Other: Fecal transplantation

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Örebro, Sweden, 70185
    • University hospital Örebro

Participation Criteria

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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)	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)	2 months
Effect of fecal transplantation on IBS patients' composition of mucosal microbiota (HITChip analysis)	2 months
Effect of fecal transplantation on IBS patients' composition of fecal microbiota (HITChip analysis)	6 months
Effect of fecal transplantation on IBS patients' mucosal immune cell composition (lymphocyte fingerprinting using flow cytometry)	2 months
Effect of fecal microbiota transplantation on the symptoms of IBS patients using the IBS - severity scoring system (IBS-SSS)	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)	6 months
Effect of fecal microbiota transplantation on the symptoms of IBS patients using the hospital and anxiety depression scale (HADS)	6 months
Effect of fecal microbiota transplantation on the general health of IBS patients using the SF-36 survey	6 months

Collaborators and Investigators

• Sponsor: 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

Study record dates

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

• Keywords: IBS; irritable bowel syndrome; microbiota transplantation; Fecal transplantation
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: 2013/180