Irritable Bowel Syndrome
Conditions
Keywords
Irritable Bowel Syndrome, Fecal Microbiota Transplantation, Microbiota
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.
Interventions
DIETARY_SUPPLEMENTFMT capsules
25 capsules per day for 12 days
DIETARY_SUPPLEMENTFMT placebo
25 capsules per day for 12 days
Sponsors
Hvidovre University Hospital
University of Aarhus
Aleris-Hamlet Hospitaler København
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| symptoms score | 12 weeks | Measured by the Irritable bowel syndrome - severity symptom score (IBS-SSS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in microbiota diversity | Day 4, 4 weeks, 12 weeks and 24 weeks | Measured by DNA sequencing |
| Microbiota diversity IBS patients | Baseline | Measured by DNA sequencing |
| Microbiota diversity in healthy donors | Baseline | Measured by DNA sequencing. To compare with the recipients (IBS patients) |
| Change in Irritable Bowel Syndrome-Quality of Life (IBS-QOL) Questionnaire Scores | Baseline, 4 weeks, 12 weeks and 24 weeks | — |
Countries
Denmark
Outcome results
None listed