Clinical trial NCT01896635: Faecal Microbiota Transplantation in Ulcerative Colitis
Official title: Faecal Microbiota Transplantation for Chronic Active Ulcerative Colitis - A Randomised Double Blind Controlled Study of Efficacy & Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Inflammatory Bowel Disease
Keywords: Ulcerative Colitis
Inflammatory Bowel Disease
Fecal Transplantation
Fecal Microbiota Transplantation
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
First posted: 2013-07-11
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Ulcerative colitis \>3 months duration
* Active mild-moderate ulcerative colitis (Mayo 4-10)
* Ulcerative colitis of any extent except isolated proctitis \< 5cm
* Live within driving distance of clinical site (to attend multiple study visits)

Exclusion Criteria:

* Pregnancy
* Active gastrointestinal infection
* Other gastrointestinal disease / comorbidities
* Prior colonic surgery
* Recent antibiotic or probiotic use
* Prednisone \> 20mg
* Monoclonal antibody immunosuppressive therapy

Primary outcomes:
measure: Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores
timeFrame: 8 weeks
Secondary outcomes:
measure: Clinical remission as measured by Mayo subscores
timeFrame: 8 weeks
measure: Clinical response as measured by Mayo subscores
timeFrame: 8 weeks
measure: Endoscopic healing as measured by UCEIS
timeFrame: 8 weeks
measure: Treatment failure rate as defined by Mayo subscores
timeFrame: 8 weeks
measure: Quality of life as measured by IBDQ
timeFrame: 8 weeks
measure: Safety and tolerability as measured by adverse event data
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Bankstown-Lidcombe Hospital
state: New South Wales
city: Nambour
country: Australia
facility: Nambour General Hospital
state: Queensland
Study officials:
affiliation: University of New South Wales
name: Hazel Mitchell, BSc PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St Vincent's Hospital, Sydney
name: Alissa Walsh, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Nambour General Hospital, Queensland
name: Johan van den Bogaerde, MBChB PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bankstown-Lidcombe Hospital, Sydney
name: Douglas Samuel, MBBS MMed
role: PRINCIPAL_INVESTIGATOR
affiliation: University of New South Wales
name: Nadeem O Kaakoush, BSc PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Melbourne
name: Michael Kamm, MBBS MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.