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The purpose of this study is to evaluate the safety profile and to obtain an indication as to the therapeutic effect of QBECO induction treatment on clinical improvement in moderate to severe Crohn's Disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QBECO | Experimental | Individualized maintenance dose ranging from 0.01 - 0.2 mL, administered subcutaneously, every other day for a maximum of 16 weeks |
|
| Placebo | Placebo Comparator | Individualized maintenance dose ranging from 0.01 - 0.2 mL, administered subcutaneously, every other day for a maximum of 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QBECO | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Assessing adverse events, concomitant therapies, clinical chemistry, hematology, urinalysis chemistry | 8 weeks |
| Clinical improvement | Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical remission | Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline | 8 weeks |
| Clinical response | Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M D | Qu Biologics Inc. | Study Director |
| M D | GI Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N 4Z6 | Canada | ||
| University of Alberta Zeidler Ledcor Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31380382 | Derived | Sutcliffe S, Kalyan S, Pankovich J, Chen JMH, Gluck R, Thompson D, Bosiljcic M, Bazett M, Fedorak RN, Panaccione R, Axler J, Marshall JK, Mullins DW, Kabakchiev B, McGovern DPB, Jang J, Coldman A, Vandermeirsch G, Bressler B, Gunn H. Novel Microbial-Based Immunotherapy Approach for Crohn's Disease. Front Med (Lausanne). 2019 Jul 19;6:170. doi: 10.3389/fmed.2019.00170. eCollection 2019. |
| Label | URL |
|---|---|
| Informational website for this trial | View source |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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|
| 8 weeks |
| Intestinal inflammation | Assessing the change in fecal calprotectin from baseline | 8 weeks |
| Systemic inflammation | Assessing the change in C-reactive protein (CRP) from baseline | 8 weeks |
| Edmonton |
| Alberta |
| T6G 2X8 |
| Canada |
| GI Research Institute | Vancouver | British Columbia | V6Z 2K5 | Canada |
| Toronto Digestive Disease Associates | Vaughan | Ontario | L4L 4Y7 | Canada |