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Not due to safety concerns, but changes in strategy which this trial no longer fulfills.
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To explore the safety of FE 999322 (microbiota suspension) and FE 999324 (microbiota capsule) versus placebo in subjects with active mild to moderate ulcerative colitis (UC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FE 999322 | Experimental | Microbiota suspension |
|
| FE 999324 | Experimental | Microbiota capsule |
|
| Placebo FE 999322 | Placebo Comparator | Placebo suspension |
|
| Placebo FE 999324 | Placebo Comparator | Placebo capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microbiota suspension | Drug | Microbiota suspension |
| |
| Microbiota capsule |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent adverse events from baseline to week 52 | From baseline to week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Compliance | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ferring Investigational Site | North Little Rock | Arkansas | 72117 | United States | ||
| Ferring Investigational Site |
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| Drug |
Microbiota capsule |
|
| Placebo suspension | Drug | Placebo suspension |
|
| Placebo capsule | Drug | Placebo capsule |
|
| Hamden |
| Connecticut |
| 06518 |
| United States |
| Ferring Investigational Site | Inverness | Florida | 34452 | United States |
| Ferring Investigational Site | Jacksonville | Florida | 32256 | United States |
| Ferring Investigational Site | Orange City | Florida | 32763 | United States |
| Ferring Investigational Site | Glenview | Illinois | 60026 | United States |
| Ferring Investigational Site | Gurnee | Illinois | 60031 | United States |
| Ferring Investigational Site | Shreveport | Louisiana | 71105 | United States |
| Ferring Investigational Site | Boston | Massachusetts | 02115 | United States |
| Ferring Investigational Site | Oklahoma City | Oklahoma | 73102 | United States |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D064307 | Microbiota |
| ID | Term |
|---|---|
| D008827 | Microbiological Phenomena |
| D058448 | Biota |
| D044822 | Biodiversity |
| D017753 | Ecosystem |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D004778 | Environment and Public Health |
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