RT Journal Article
SR Electronic
T1 STOP-Colitis pilot trial protocol: a prospective, open-label, randomised pilot study to assess two possible routes of faecal microbiota transplant delivery in patients with ulcerative colitis
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e030659
DO 10.1136/bmjopen-2019-030659
VO 9
IS 11
A1 Mohammed Nabil Quraishi
A1 Mehmet Yalchin
A1 Clare Blackwell
A1 Jonathan Segal
A1 Naveen Sharma
A1 Peter Hawkey
A1 Victoria McCune
A1 Ailsa L Hart
A1 Daniel Gaya
A1 Natalie J Ives
A1 Laura Magill
A1 Shrushma Loi
A1 Catherine Hewitt
A1 Konstantinos Gerasimidis
A1 Nicholas James Loman
A1 Richard Hansen
A1 Christel McMullan
A1 Jonathan Mathers
A1 Christopher Quince
A1 Nicola Crees
A1 Tariq Iqbal
YR 2019
UL http://bmjopen.bmj.com/content/9/11/e030659.abstract
AB Introduction Imbalance of the gut microbiome is key to the pathogenesis of ulcerative colitis (UC). Faecal microbiota transplant (FMT) is the transfer of homogenised and filtered faeces from a healthy individual to the gastrointestinal tract of a patient with disease. Published datasets show a positive signal for the use of FMT to treat UC, but the optimal route and dose of FMT remain unanswered.Methods and analysis This prospective, multi-centre open-label, randomised pilot study will assess two possible routes of FMT delivery, via the nasogastric (NG) route or by delivery to the COLON, in 30 patients with active UC recruited from three sites in the UK. Stool will be collected from healthy screened donors, processed, frozen and stored under a Medicines and Healthcare products Regulatory Agency (MHRA) “specials” manufacturing licence held at the University of Birmingham Microbiome Treatment Centre. Thawed FMT samples will be administered to patients either via eight nasogastric infusions given initially over 4 days starting on the day of randomisation, and then again for 4 days in week 4 for foregut delivery (total of 240 g of stool) or via one colonoscopic infusion followed by seven weekly enemas according to the hindgut protocol (total of 360 g of stool). Patients will be followed up weekly for 8 weeks, and then at 12 weeks. The aims of this pilot study are (1) to determine which FMT administration route (NG or COLON) should be investigated in a randomised double-blind, placebo-controlled trial and (2) to determine if a full randomised controlled trial is feasible. The primary outcome will be a composite assessment of both qualitative and quantitative data based on efficacy (clinical response), acceptability and safety. At the end of the pilot study, decisions will be made regarding the feasibility of a full randomised double-blind, placebo-controlled trial and, if deemed feasible, which route of administration should be used in such a study.Ethics and dissemination Ethical approval for this study has been obtained from the East Midlands-Nottingham Research Ethics Committee (REC 17/EM/0274). At the end of the study, findings will be reported at national and international gastroenterology meetings and published in peer-reviewed journals.Trial registration number ISRCTN74072945