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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03264690

Acronym

ETERNITY

Enrollment

Registered

2017-08-29

Start date

2017-09-21

Completion date

2020-01-16

Last updated

2020-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease

Keywords

Crohn's disease, Ulcerative colitis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
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.

Countries

South Korea

Outcome results