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

Inflammatory Bowel Disease Clinical Trial

— ETERNITY  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03264690
• Other study ID #: D2E7-M082-602
• Status: Completed
• Start date: September 21, 2017
• Est. completion date: January 16, 2020

Study information

• Verified date: November 2019
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 16, 2020
• Est. primary completion date: January 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases

Locations

Country	Name	City	State
Korea, Republic of	Eisai Trial Site # 1	Seoul
Korea, Republic of	Eisai Trial Site # 2	Seoul
Korea, Republic of	Eisai Trial Site # 3	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Korea Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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