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

NCT03264690 — Completed, 40 participants, Eisai Korea Inc.

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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

RegistryNCT03264690, acronym ETERNITY
StatusCompleted
Study typeObservational
Enrollment40 (Actual)
SponsorEisai Korea Inc. (Industry)
ConditionsInflammatory Bowel Disease
Datesstart 2017-09-21, primary completion 2020-01-16, completion 2020-01-16, first posted 2017-08-29, last updated 2020-03-10
Locations3 sites in South Korea

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All trials for Inflammatory Bowel Disease

-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-TNF) treatment.

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+Arms and interventions

ArmTypeInterventionsDescription
Microbial composition measured from IBD and non-IBD groupsParticipants with inflammatory bowel disease (IBD) and non-IBD will be measured for microbial composition.

+Outcome measures

Primary outcomes

  • Change in the composition of the microbiome after anti-tumour necrosis factor (anti-TNF) treatment for inflammatory bowel disease (IBD) at Month 3 [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.

Secondary outcomes

  • The difference in the composition of the microbiome at baseline between IBD participants and non-IBD participants [Baseline]: 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.
  • Disease activity will be assessed by Crohn's Disease Activity Index (CDAI) or Mayo score for ulcerative colitis (UC) [Up to 3 months]: Disease activity will be assessed by CDAI to quantify the symptoms.
  • 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 [Baseline; 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.
  • Change from baseline in calprotectin at Month 3 [Baseline; Month 3]: Fecal calprotectin can indicate inflammation in the intestines.
  • Number of participants with abnormal, clinically significant vital signs [Up to 3 months]: Clinical significance will be determined by the investigator.

+Eligibility

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

+Locations (3)

FacilityCityCountryStatus
Eisai Trial Site # 1SeoulSouth Korea
Eisai Trial Site # 2SeoulSouth Korea
Eisai Trial Site # 3SeoulSouth Korea