Status:
COMPLETED
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
Lead Sponsor:
Eisai Korea Inc.
Conditions:
Inflammatory Bowel Disease
Eligibility:
All Genders
19+ years
Brief Summary
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...
Eligibility Criteria
Inclusion
- Inclusion/ Exclusion Criteria:
- 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)
- Exclusion Criteria for IBD participants:
- Contraindication to anti-TNF including active tuberculosis (TB), sepsis, or other severe opportunistic infection, etc.
- Inclusion/ Exclusion Criteria:
- 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
- Exclusion Criteria for non-IBD participants:
- Participants who have been on medication to treat underlying disease for the previous 3 months
Exclusion
Key Trial Info
Start Date :
September 21 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 16 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03264690
Start Date
September 21 2017
End Date
January 16 2020
Last Update
March 10 2020
Active Locations (3)
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1
Eisai Trial Site # 1
Seoul, South Korea
2
Eisai Trial Site # 2
Seoul, South Korea
3
Eisai Trial Site # 3
Seoul, South Korea