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

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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. / Quraishi, Mohammed Nabil; Yalchin, Mehmet ; Blackwell, Clare ; Segal, Jonathan P; Sharma, Naveen; Hawkey, Peter; McCune, Victoria; Hart, Ailsa; Gaya, Daniel R; Ives, Natalie; Magill, Laura; Loi, Shrushma; Hewitt, Catherine; Gerasimidis, Konstantinos; Loman, Nicholas; Hansen, Richard; McMullan, Christel; Mathers, Jonathan; Quince, Christopher; Crees, Nicola ; Iqbal, Tariq.

In: BMJ open, Vol. 9, No. 11, e030659, 11.11.2019.

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Quraishi, Mohammed Nabil ; Yalchin, Mehmet ; Blackwell, Clare ; Segal, Jonathan P ; Sharma, Naveen ; Hawkey, Peter ; McCune, Victoria ; Hart, Ailsa ; Gaya, Daniel R ; Ives, Natalie ; Magill, Laura ; Loi, Shrushma ; Hewitt, Catherine ; Gerasimidis, Konstantinos ; Loman, Nicholas ; Hansen, Richard ; McMullan, Christel ; Mathers, Jonathan ; Quince, Christopher ; Crees, Nicola ; Iqbal, Tariq. / 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. In: BMJ open. 2019 ; Vol. 9, No. 11.

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@article{db27c1cc8614426096f38e66dc0fd7a9,
title = "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",
abstract = "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.",
keywords = "faecal microbiota transplant, ulcerative colitis, randomised controlled pilot study",
author = "Quraishi, {Mohammed Nabil} and Mehmet Yalchin and Clare Blackwell and Segal, {Jonathan P} and Naveen Sharma and Peter Hawkey and Victoria McCune and Ailsa Hart and Gaya, {Daniel R} and Natalie Ives and Laura Magill and Shrushma Loi and Catherine Hewitt and Konstantinos Gerasimidis and Nicholas Loman and Richard Hansen and Christel McMullan and Jonathan Mathers and Christopher Quince and Nicola Crees and Tariq Iqbal",
year = "2019",
month = nov,
day = "11",
doi = "10.1136/bmjopen-2019-030659",
language = "English",
volume = "9",
journal = "BMJ open",
issn = "2044-6055",
publisher = "BMJ Publishing Group",
number = "11",

}

RIS

TY - JOUR

T1 - STOP-Colitis pilot trial protocol

T2 - a prospective, open-label, randomised pilot study to assess two possible routes of faecal microbiota transplant delivery in patients with ulcerative colitis

AU - Quraishi, Mohammed Nabil

AU - Yalchin, Mehmet

AU - Blackwell, Clare

AU - Segal, Jonathan P

AU - Sharma, Naveen

AU - Hawkey, Peter

AU - McCune, Victoria

AU - Hart, Ailsa

AU - Gaya, Daniel R

AU - Ives, Natalie

AU - Magill, Laura

AU - Loi, Shrushma

AU - Hewitt, Catherine

AU - Gerasimidis, Konstantinos

AU - Loman, Nicholas

AU - Hansen, Richard

AU - McMullan, Christel

AU - Mathers, Jonathan

AU - Quince, Christopher

AU - Crees, Nicola

AU - Iqbal, Tariq

PY - 2019/11/11

Y1 - 2019/11/11

N2 - 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.

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.

KW - faecal microbiota transplant

KW - ulcerative colitis

KW - randomised controlled pilot study

UR - http://www.scopus.com/inward/record.url?scp=85074903103&partnerID=8YFLogxK

U2 - 10.1136/bmjopen-2019-030659

DO - 10.1136/bmjopen-2019-030659

M3 - Article

VL - 9

JO - BMJ open

JF - BMJ open

SN - 2044-6055

IS - 11

M1 - e030659

ER -