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

Completed

• Conditions: Inflammatory Bowel Disease

• Registration Number: NCT03264690
• Lead Sponsor: Eisai Korea Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-25
• Study First Submitted QC: 2017-08-25
• Study First Posted: 2017-08-29
• Study Start: 2017-09-21
• Status Verified: 2019-11
• Primary Completion: 2020-01-16
• Study Completion: 2020-01-16
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change from baseline in calprotectin at Month 3	Baseline; Month 3	Fecal calprotectin can indicate inflammation in the intestines.
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.
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.
Number of participants with abnormal, clinically significant vital signs	Up to 3 months	Clinical significance will be determined by the investigator.

Trial Locations

Locations (3)

Eisai Trial Site # 2; 🇰🇷 Seoul, Korea, Republic of

Eisai Trial Site # 1; 🇰🇷 Seoul, Korea, Republic of

Eisai Trial Site # 3; 🇰🇷 Seoul, Korea, Republic of