Clostridioides Difficile Infection, Inflammatory Bowel Diseases, Ulcerative Colitis
Conditions
Keywords
Fecal microbiota transplantation, FMT, Lyophilized fecal microbiota transplantation, LFMT
Brief summary
This is a multi-centre, randomised controlled trial comparing fecal microbiota transplantation to placebo in an expanded ulcerative colitis population: a feasibility study (FRONTIER-UC) to determine whether a full-scale randomized controlled trial (RCT) to investigate fecal microbiota transplantation (FMT) in ulcerative colitis (UC) is feasible.
Detailed description
This is a randomized, double blind, placebo-controlled trial for UC patients with active disease. Participants will be grouped into one of two categories 1. Add to current therapy (i.e., adjunct therapy) or 2. Initiate or switch to a new advanced agent (i.e., co-administration) The study will recruit 85 outpatients at 3 Canadian healthcare centres
Interventions
OTHERLyophilized Fecal Microbiota Transplantation (LFMT)
LFMT by oral capsules
OTHERPlacebo
Placebo capsules does not contain FMT
Sponsors
University of Alberta
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Multi-center, randomized, double-blind, placebo-controlled feasibility study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or older 2. Able to provide informed consent 3. Established UC diagnosis through standard endoscopic and histologic criteria 4. Active UC 5. Use of effective contraception method for women of childbearing potential for at least 4 weeks prior to receiving study treatment and for the duration of the trial 6. Willing and able to comply with all required study procedures
Exclusion criteria
1. Severe UC requiring hospitalization 2. Crohn's disease or indeterminate colitis 3. Irritable bowel syndrome 4. Intestinal infection within 4 weeks of enrollment 5. Evidence of toxic megacolon or gastrointestinal perforation on imaging 6. Planned colectomy 7. Abdominal surgery within 60 days of enrollment 8. Neutropenia with absolute neutrophil count \<0.5 x 109/L 9. Peripheral white blood cell count \> 35.0 x 109/L and fever (\>38C) 10. Planned or actively taking another investigational product 11. Uncontrolled medical conditions such as psychiatric disorders or substance abuse 12. Severe underlying disease such that the patient is not expected to survive for at least 30 days 13. Pregnancy or breastfeeding 14. Unwilling to discontinue non-dietary probiotic 15. Antibiotic use 30 days prior to enrollment or anticipated need for systemic antibiotic use during study 16. FMT for any reason within 6 months of enrollment 17. Investigator's judgement that enrolment is not in the best interest of the patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Steroid-free endoscopic remission | At 8 weeks | Steroid-free endoscopic remission is defined as either 1. Mayo endoscopy score (MES)= 0 OR 2. MES=1 + FC \<150 µg/g |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious adverse events [SAE] | up to week 24 or at time of withdrawal | SAEs including infections attributable to FMT, hospitalization due to UC exacerbation or complications related to FMT, or colectomy due to UC |
| Adverse outcomes | up to week 24 or upon withdrawal | Adverse outcomes, including nausea, vomiting, worsening diarrhea or abdominal pain |
| Quality of Life- sIBDQ | Baseline to 8 weeks and 24 weeks | Changes in health-related quality of life measures using the short IBD questionnaire (sIBDQ) |
| Quality of Life- WPAI-IBD | Baseline to 8 weeks and weeks 24 | Changes in health-related quality of life measures using the work productivity and activity impairment questionnaire (WPAI-IBD) |
Countries
Canada
Contacts
CONTACTDina Kao, MD,FRCPC
Outcome results
None listed