Aleris Hamlet Hospitaler, København
Copenhagen, Søborg, 2760, Denmark
NCT Number: NCT02788071
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).
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Notify Me18 year–60 year
All sexes
Interventional
Phase 2 / Phase 3
Copenhagen, Søborg, 2760, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Inclusion criteria
for donors
Exclusion criteria
for donors
25 capsules per day for 12 days
25 capsules per day for 12 days
Time frame: 12 weeks
Measured by the Irritable bowel syndrome - severity symptom score (IBS-SSS)
Time frame: Day 4, 4 weeks, 12 weeks and 24 weeks
Measured by DNA sequencing
Time frame: Baseline
Measured by DNA sequencing
Time frame: Baseline
Measured by DNA sequencing. To compare with the recipients (IBS patients)
Time frame: Baseline, 4 weeks, 12 weeks and 24 weeks
Aleris-Hamlet Hospitaler København
Other
Effect of Fecal Microbiota Transplantation in Irritable Bowel Syndrome (IBS) - a Randomized, Double-blind Placebo Controlled Pilot Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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