Clinical trial NCT03264690: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease
Keywords: Crohn's disease
Ulcerative colitis
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-29
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female participants diagnosed with inflammatory bowel disease (IBD) will be compared to participants with non-IBD.

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-TNF) treatment.


Eligibility criteria: 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

Primary outcomes:
measure: Change in the composition of the microbiome after anti-tumour necrosis factor (anti-TNF) treatment for inflammatory bowel disease (IBD) at Month 3
timeFrame: Month 3
Secondary outcomes:
measure: The difference in the composition of the microbiome at baseline between IBD participants and non-IBD participants
timeFrame: Baseline
measure: Disease activity will be assessed by Crohn's Disease Activity Index (CDAI) or Mayo score for ulcerative colitis (UC)
timeFrame: Up to 3 months
measure: 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
timeFrame: Baseline; Month 3
measure: Change from baseline in calprotectin at Month 3
timeFrame: Baseline; Month 3
measure: Number of participants with abnormal, clinically significant vital signs
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Eisai Trial Site # 1
city: Seoul
country: Korea, Republic of
facility: Eisai Trial Site # 2
city: Seoul
country: Korea, Republic of
facility: Eisai Trial Site # 3
Study officials:
References: