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This study will be conducted to observe the difference in microbiome composition between healthy participants and inflammatory bowel disease (IBD) participants with no anti-tumor necrosis factor (anti-TNF) treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microbial composition measured from IBD and non-IBD groups | Participants with inflammatory bowel disease (IBD) and non-IBD will be measured for microbial composition. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in the composition of the microbiome after anti-tumour necrosis factor (anti-TNF) treatment for inflammatory bowel disease (IBD) at Month 3 | Microbiome is the microorganisms in a particular environment (including the body or a part of the body). Changes in the microbiome in fecal, blood, saliva, and urine samples before and after anti-TNF treatment will be assessed. | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| The difference in the composition of the microbiome at baseline between IBD participants and non-IBD participants | Microbiome is the microorganisms in a particular environment (including the body or a part of the body). Changes in the microbiome in fecal, blood, saliva, and urine samples before and after anti-TNF treatment will be assessed. | Baseline |
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Inclusion/ Exclusion Criteria:
Inclusion Criteria For Inflammatory Bowel Disease (IBD) participants:
Exclusion Criteria for IBD participants:
Inclusion/ Exclusion Criteria:
Inclusion Criteria for non-IBD participants:
Exclusion Criteria for non-IBD participants:
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Male and female participants diagnosed with inflammatory bowel disease (IBD) will be compared to participants with non-IBD.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eisai Trial Site # 1 | Seoul | South Korea | ||||
| Eisai Trial Site # 2 |
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| Disease activity will be assessed by Crohn's Disease Activity Index (CDAI) or Mayo score for ulcerative colitis (UC) | Disease activity will be assessed by CDAI to quantify the symptoms. | Up to 3 months |
| Correlation in the composition of the microbiome at baseline and disease activity will be assessed as measured by CDAI or Mayo score at Month 3 | The composition of the microbiome at baseline will be correlated to disease activity which is assessed as measured by CDAI or Mayo score at Month 3. | Baseline; Month 3 |
| Change from baseline in calprotectin at Month 3 | Fecal calprotectin can indicate inflammation in the intestines. | Baseline; Month 3 |
| Number of participants with abnormal, clinically significant vital signs | Clinical significance will be determined by the investigator. | Up to 3 months |
| Seoul |
| South Korea |
| Eisai Trial Site # 3 | Seoul | South Korea |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
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