An observational study in Inflammatory Bowel Disease, sponsored by Eisai Korea Inc.. Completed at 3 sites in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-10.
Sponsored by Eisai Korea Inc. · Observational
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.
Male and female participants diagnosed with inflammatory bowel disease (IBD) will be compared to participants with non-IBD.
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:
Participants with inflammatory bowel disease (IBD) and non-IBD will be measured for microbial composition.
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.
Time frame: Month 3
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.
Time frame: Baseline
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.
Time frame: 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.
Time frame: Baseline; Month 3
Change from baseline in calprotectin at Month 3
Fecal calprotectin can indicate inflammation in the intestines.
Time frame: Baseline; Month 3
Number of participants with abnormal, clinically significant vital signs
Clinical significance will be determined by the investigator.
Time frame: Up to 3 months
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Eisai Korea Inc.