Effect of Fecal Microbiota Transplantation in Irritable Bowel Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate if fecal microbiota transplantation (FMT) will result in improvement in clinical outcome in patients with irritable bowel syndrome (IBS).

Detailed Description
-----------------
Irritable bowel syndrome (IBS) is the most commonly diagnosed gastrointestinal condition. IBS is associated with a high use of health-care costs and can substantially reduce quality of life and work productivity. Several studies have demonstrated that the composition of the gut microbiota in IBS patients is different from healthy controls. Fecal microbiota transplantation (FMT) could therefore be a treatment option for IBS patients by exchanging the microbiota of an IBS patient with the microbiota of a healthy donor.

Official Title
-----------------
Effect of Fecal Microbiota Transplantation in Irritable Bowel Syndrome (IBS) - a Randomized, Double-blind Placebo Controlled Pilot Study

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: FMT capsules
* Dietary Supplement: FMT placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fulfilled Rome III diagnostic criteria for IBS Moderate-severe disease activity (IBS-Symptom Severity Score ≥175) Able to read and speak Danish Normal colonoscopy at age ≥ 40 years (performed within 1 year) or blood in stool Exclusion Criteria: Other chronic gastrointestinal disease Positive fecal sample with enteropathogenic microorganisms or Clostridium difficile Positive screening for HIV, Hepatitis B or HCV antibody Surgical interventions in the gastrointestinal region (except for appendectomy, hernia repair, cholecystectomy, and gynecological and urological procedures) Psychiatric disorder Fecal calprotectin ≥ 50 mg/kg Abuse of alcohol or drugs Medications other than birth control pills, hormone supplements, allergies and asthma agents, blood pressure and cholesterol lowering agents, proton pump inhibitors and non-prescription medicines Abnormal screening biochemistry Abnormal colonoscopy findings Pregnant, planned pregnancy or breastfeeding females Ingestion of probiotics or antibiotics < 8 weeks before the inclusion Inclusion criteria for donors Age between 18-45 years Past and current healthy Normal weight (BMI between 18,5-24,9 kg/m2) Normal bowel movements (defined as 1-2 per day and type 3-4 at Bristol Stool Form Scale) No medication consumption Exclusion criteria for donors Known or high risk of infectious diseases such as HIV, hepatitis A, B or C Positive stool sample for C. difficile toxin, parasites or other pathogens Antibiotic treatment in the past 6 months Abuse of alcohol or drugs Smoking Tattoo or body piercing within the last 6 months Allergy, asthma or eczema Family history of gastrointestinal diseases Participation in high-risk sexual behaviors Born by Caesarean section

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FMT capsules<br>FMT capsules | Dietary Supplement: FMT capsules<br>* 25 capsules per day for 12 days<br>|
| Placebo Comparator: FMT placebo<br>Placebo capsules | Dietary Supplement: FMT placebo<br>* 25 capsules per day for 12 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptoms score | Measured by the Irritable bowel syndrome - severity symptom score (IBS-SSS) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in microbiota diversity | Measured by DNA sequencing | Day 4, 4 weeks, 12 weeks and 24 weeks | 
| Microbiota diversity IBS patients | Measured by DNA sequencing | Baseline | 
| Microbiota diversity in healthy donors | Measured by DNA sequencing. To compare with the recipients (IBS patients) | Baseline | 
| Change in Irritable Bowel Syndrome-Quality of Life (IBS-QOL) Questionnaire Scores |  | Baseline, 4 weeks, 12 weeks and 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Irritable Bowel Syndrome, Fecal Microbiota Transplantation, Microbiota