Clinical Trial: Effect of Fecal Microbiota Transplantation in Irritable Bowel Syndrome

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Aleris-Hamlet Hospitaler København

Current Primary Outcome: symptoms score [ Time Frame: 12 weeks ]

Measured by the Irritable bowel syndrome - severity symptom score (IBS-SSS)


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Aleris-Hamlet Hospitaler København

Dates:
Date Received: May 30, 2016
Date Started: October 2016
Date Completion: June 2017
Last Updated: December 2, 2016
Last Verified: December 2016