STOP-Colitis Pilot Trial
Research type
Research Study
Full title
Prospective, open-label, randomised pilot study to assess two possible routes of Faecal Microbiota Transplant (FMT) delivery in patients with ulcerative colitis.
IRAS ID
170888
Contact name
Tariq Iqbal
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2015-005753-12
Duration of Study in the UK
0 years, 6 months, 2 days
Research summary
A prospective, open-label, randomised pilot study to assess two possible routes of Faecal Microbiota Transplant (FMT) delivery in patients with ulcerative colitis: The human body contains vastly more bacteria (bugs) than human cells and it is becoming increasingly clear that these bacteria have important and previously unrecognised effects on the body. The majority of these bacteria reside in the colon and it is now known that the bacterial population (microbiome) in patients with UC is different from that of healthy people. Over the past 10 years doctors and patients from many countries have attempted to change the microbiome in UC using FMT (faecal microbiota transplant (transfer of faeces from a healthy individual to a person with disease)), and their attempts have suggested that this may be an effective treatment. However there has never been a study with enough patients to truly assess the effectiveness of this treatment. We are initially conducting a small “pilot” study to compare the two available ways of giving FMT (into the stomach via a naso-gastric tube or the directly into the colon). The pilot trial will recruit 30 patients, who have had UC for at least 3 months, aged 12-70, from 3 UK centres over 6 months. They will be randomly allocated to receive either FMT via naso-gastric (NG) route or colonic route. Stool and urine samples will be collected for genetic testing and microbe studies. We will make a careful comparison of the effectiveness and acceptability of the two possible ways of giving FMT. Although the pilot study will be too small to say for certain whether FMT works or not, we will carefully look for signals that the method is working before going forward with either method of FMT into the larger RCT. The trial is funded by the NIHR EME Programme.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
17/EM/0274
Date of REC Opinion
22 Sep 2017
REC opinion
Further Information Favourable Opinion