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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
52
25 capsules per day for 12 days
25 capsules per day for 12 days
Aleris Hamlet Hospitaler, København
Copenhagen, Søborg, Denmark
symptoms score
Measured by the Irritable bowel syndrome - severity symptom score (IBS-SSS)
Time frame: 12 weeks
Change in microbiota diversity
Measured by DNA sequencing
Time frame: Day 4, 4 weeks, 12 weeks and 24 weeks
Microbiota diversity IBS patients
Measured by DNA sequencing
Time frame: Baseline
Microbiota diversity in healthy donors
Measured by DNA sequencing. To compare with the recipients (IBS patients)
Time frame: Baseline
Change in Irritable Bowel Syndrome-Quality of Life (IBS-QOL) Questionnaire Scores
Time frame: Baseline, 4 weeks, 12 weeks and 24 weeks
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