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| Name | Class |
|---|---|
| University of Calgary | OTHER |
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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.
This is a randomized, double blind, placebo-controlled trial for UC patients with active disease.
Participants will be grouped into one of two categories
Add to current therapy (i.e., adjunct therapy)
or
Initiate or switch to a new advanced agent (i.e., co-administration)
The study will recruit 85 outpatients at 3 Canadian healthcare centres
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjunct therapy group (LFMT) | Experimental | Induction phase: 4 capsules a day x 1 week, 2 capsules a day x 1 week, followed by 1 capsule daily x 6 weeks Maintenance phase: 1 capsule daily x 16 weeks |
|
| Adjunct therapy group (Placebo) | Placebo Comparator | The placebo capsules will appear identical to LFMT capsules and same dosing will apply. |
|
| Co-Administration therapy group (LFMT) | Experimental | Induction phase: 4 capsules a day x 1 week, 2 capsules a day x 1 week, followed by 1 capsule daily x 6 weeks Maintenance phase: 1 capsule daily x 16 weeks |
|
| Co-Administration therapy group (Plcebo) | Placebo Comparator | The placebo capsules will appear identical to LFMT capsules and same dosing will apply. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lyophilized Fecal Microbiota Transplantation (LFMT) | Other | LFMT by oral capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Steroid-free endoscopic remission | Steroid-free endoscopic remission is defined as either
| At 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serious adverse events [SAE] | SAEs including infections attributable to FMT, hospitalization due to UC exacerbation or complications related to FMT, or colectomy due to UC | up to week 24 or at time of withdrawal |
| Adverse outcomes |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Evaluation of rate of participant recruitment | Study start to the end of recruitment |
| Consent rate | Evaluation of rate of participant consent to participate |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dina Kao, MD,FRCPC | Contact | 780-492-5257 | dkao@ualberta.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Not yet recruiting | Calgary | Alberta | T2N-1N4 | Canada |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Multi-center, randomized, double-blind, placebo-controlled feasibility study
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| Placebo | Other | Placebo capsules does not contain FMT |
|
Adverse outcomes, including nausea, vomiting, worsening diarrhea or abdominal pain
| up to week 24 or upon withdrawal |
| Quality of Life- sIBDQ | Changes in health-related quality of life measures using the short IBD questionnaire (sIBDQ) | Baseline to 8 weeks and 24 weeks |
| Quality of Life- WPAI-IBD | Changes in health-related quality of life measures using the work productivity and activity impairment questionnaire (WPAI-IBD) | Baseline to 8 weeks and weeks 24 |
| Study start to the end of recruitment |
| Symptom remission | Symptom remission, defined as partial Mayo score <2 with no individual subscore >1 | 8 weeks and 24 weeks |
| Symptom response | Symptom response, defined as reduction in partial Mayo score by >2 points from baseline and >30% from baseline and decrease in rectal bleeding score >1 point from baseline | At weeks 8 and 24 |
| Endoscopic improvement | Endoscopic improvement, defined as a decrease of Mayo endoscopy score (MES) by at least 1 point | At week 8 and 24 |
| UC therapy escalation | Avoidance of UC therapy escalation | At weeks 8 and 24 |
| Stool microbial compositions | Changes in stool microbial compositions | between week 0 to 8 weeks and week 0 to 24 weeks |
| University of Alberta | Recruiting | Edmonton | Alberta | T6G2R3 | Canada |
|
| D003108 |
| Colonic Diseases |
| D007410 | Intestinal Diseases |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |