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 (ETERNITY)

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

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Disease

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Eisai Trial Site # 1
  • Seoul, Korea, Republic of
    • Eisai Trial Site # 2
  • Seoul, Korea, Republic of
    • Eisai Trial Site # 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Male and female participants diagnosed with inflammatory bowel disease (IBD) will be compared to participants with non-IBD.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Microbial composition measured from IBD and non-IBD groups; Participants with inflammatory bowel disease (IBD) and non-IBD will be measured for microbial composition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Month 3

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Eisai Korea Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2017
• Primary Completion (Actual): January 16, 2020
• Study Completion (Actual): January 16, 2020

Study Registration Dates

• First Submitted: August 25, 2017
• First Submitted That Met QC Criteria: August 25, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Crohn's disease; Ulcerative colitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases
• Other Study ID Numbers: D2E7-M082-602

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No