NCT01896635
Completed
Phase 2
Faecal Microbiota Transplantation for Chronic Active Ulcerative Colitis - A Randomised Double Blind Controlled Study of Efficacy & Safety
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Ulcerative Colitis
- Sponsor
- The University of New South Wales
- Enrollment
- 81
- Locations
- 3
- Primary Endpoint
- Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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
Investigators
Dr. Sudarshan Paramsothy
Gastroenterologist / PhD candidate
The University of New South Wales
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
Outcomes
Primary Outcomes
Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores
Time Frame: 8 weeks
Secondary Outcomes
- Clinical remission as measured by Mayo subscores(8 weeks)
- Endoscopic healing as measured by UCEIS(8 weeks)
- Treatment failure rate as defined by Mayo subscores(8 weeks)
- Safety and tolerability as measured by adverse event data(8 weeks)
- Clinical response as measured by Mayo subscores(8 weeks)
- Quality of life as measured by IBDQ(8 weeks)
Study Sites (3)
Loading locations...
Similar Trials
Unknown
Early Phase 1
FMT for Steroid Resistant Gut Acute GVHDStem Cell Transplant ComplicationsAcute Graft-Versus-Host DiseaseFecal Microbiota TransplantationNCT04285424Affiliated Hospital to Academy of Military Medical Sciences30
Completed
Phase 2
FMT in Ulcerative Colitis-Associated PouchitisUlcerative Colitis Associated PouchitisNCT02049502Virginia O. Shaffer8
Unknown
Phase 1
Fecal Microbiota Transplantation for Treatment of Refractory Graft Versus Host Disease-a Pilot StudyFecal Microbiota Transplantation in GVHDNCT03549676Shanghai Children's Medical Center15
Not yet recruiting
Not Applicable
Fecal Microbiota Transplantation in Reversing Drug Resistance in Unresectable HCC (TALENP004)Hepatocellular Carcinoma Non-resectableNCT06643533Fujian Provincial Hospital15
Active, not recruiting
Not Applicable
Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic SclerosisDiarrheaSystemic SclerosisNCT06333795University of Aarhus20