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The purpose of this study is to determine whether fecal microbiota transplantation (FMT) is safe and efficacious in the treatment of chronic active ulcerative colitis (UC) by conducting a randomised controlled trial
This study involves the assessment of the safety and efficacy of FMT in the treatment and induction of remission for patients with mild to moderate ulcerative colitis. It is a double blind study with patients randomised in a 1:1 manner to either active or placebo therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMT infusions | Active Comparator | FMT infusions constituted from stool provided by healthy, screened donors |
|
| Placebo arm | Placebo Comparator | Placebo infusions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMT infusions | Biological | Active FMT derived from healthy anonymous pre-screened donors |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical remission as measured by Mayo subscores | 8 weeks | |
| Clinical response as measured by Mayo subscores | 8 weeks | |
| Endoscopic healing as measured by UCEIS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hazel Mitchell, BSc PhD | University of New South Wales | Principal Investigator |
| Alissa Walsh, MBBS | St Vincent's Hospital, Sydney | Principal Investigator |
| Johan van den Bogaerde, MBChB PhD | Nambour General Hospital, Queensland | Principal Investigator |
| Douglas Samuel, MBBS MMed | Bankstown-Lidcombe Hospital, Sydney | Principal Investigator |
| Nadeem O Kaakoush, BSc PhD | University of New South Wales | Principal Investigator |
| Michael Kamm, MBBS MD | University of Melbourne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Vincent's Hospital | Sydney | New South Wales | 2010 | Australia | ||
| Bankstown-Lidcombe Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30529583 | Derived | Paramsothy S, Nielsen S, Kamm MA, Deshpande NP, Faith JJ, Clemente JC, Paramsothy R, Walsh AJ, van den Bogaerde J, Samuel D, Leong RWL, Connor S, Ng W, Lin E, Borody TJ, Wilkins MR, Colombel JF, Mitchell HM, Kaakoush NO. Specific Bacteria and Metabolites Associated With Response to Fecal Microbiota Transplantation in Patients With Ulcerative Colitis. Gastroenterology. 2019 Apr;156(5):1440-1454.e2. doi: 10.1053/j.gastro.2018.12.001. Epub 2018 Dec 6. | |
| 28214091 |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Placebo infusion | Other | Placebo infusion not containing any donor microbial material |
|
| 8 weeks |
| Treatment failure rate as defined by Mayo subscores | 8 weeks |
| Quality of life as measured by IBDQ | 8 weeks |
| Safety and tolerability as measured by adverse event data | 8 weeks |
| Sydney |
| New South Wales |
| 2200 |
| Australia |
| Nambour General Hospital | Nambour | Queensland | 4560 | Australia |
| Derived |
| Paramsothy S, Kamm MA, Kaakoush NO, Walsh AJ, van den Bogaerde J, Samuel D, Leong RWL, Connor S, Ng W, Paramsothy R, Xuan W, Lin E, Mitchell HM, Borody TJ. Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: a randomised placebo-controlled trial. Lancet. 2017 Mar 25;389(10075):1218-1228. doi: 10.1016/S0140-6736(17)30182-4. Epub 2017 Feb 15. |
| 26478682 | Derived | Paramsothy S, Walsh AJ, Borody T, Samuel D, van den Bogaerde J, Leong RW, Connor S, Ng W, Mitchell HM, Kaakoush NO, Kamm MA. Gastroenterologist perceptions of faecal microbiota transplantation. World J Gastroenterol. 2015 Oct 14;21(38):10907-14. doi: 10.3748/wjg.v21.i38.10907. |
| 26070003 | Derived | Paramsothy S, Borody TJ, Lin E, Finlayson S, Walsh AJ, Samuel D, van den Bogaerde J, Leong RW, Connor S, Ng W, Mitchell HM, Kaakoush N, Kamm MA. Donor Recruitment for Fecal Microbiota Transplantation. Inflamm Bowel Dis. 2015 Jul;21(7):1600-6. doi: 10.1097/MIB.0000000000000405. |
| D003108 |
| Colonic Diseases |
| D007410 | Intestinal Diseases |