A Prospective Study to Observe the Change in Microbiome in Human Derived Sample and the Relation With Clinical Response Before and After the Anti-TNF Treatment in IBD Patients
| Registry | NCT03264690, acronym ETERNITY |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 40 (Actual) |
| Sponsor | Eisai Korea Inc. (Industry) |
| Conditions | Inflammatory Bowel Disease |
| Dates | start 2017-09-21, primary completion 2020-01-16, completion 2020-01-16, first posted 2017-08-29, last updated 2020-03-10 |
| Locations | 3 sites in South Korea |
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All trials for Inflammatory Bowel Disease
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Microbial composition measured from IBD and non-IBD groups | Participants with inflammatory bowel disease (IBD) and non-IBD will be measured for microbial composition. |
Sex: All, ages: 19 Years to any, accepts healthy volunteers
1. Inclusion/ Exclusion Criteria:
1. Inclusion Criteria For Inflammatory Bowel Disease (IBD) participants:
* Male or female, age ≥ 19 years at the time of informed consent
* Confirmed diagnosis of IBD
* Participants who are naïve to anti-tumour necrosis factor (anti-TNF)
2. Exclusion Criteria for IBD participants:
* Contraindication to anti-TNF including active tuberculosis (TB), sepsis, or other severe opportunistic infection, etc.
2. Inclusion/ Exclusion Criteria:
1. Inclusion Criteria for non-IBD participants:
* Participants who have not been diagnosed with IBD
* Participants who don't have any other intestinal disease except IBD
* Participants who are naïve to anti-TNF
2. Exclusion Criteria for non-IBD participants:
* Participants who have been on medication to treat underlying disease for the previous 3 months| Facility | City | Country | Status |
|---|---|---|---|
| Eisai Trial Site # 1 | Seoul | South Korea | |
| Eisai Trial Site # 2 | Seoul | South Korea | |
| Eisai Trial Site # 3 | Seoul | South Korea |