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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

NCT03264690•Eisai Korea Inc.

View on ClinicalTrials.gov

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

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•* 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)
•* 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

Exclusion Criteria

•* Contraindication to anti-TNF including active tuberculosis (TB), sepsis, or other severe opportunistic infection, etc.
•* Participants who have been on medication to treat underlying disease for the previous 3 months

Locations (3)

Eisai Trial Site # 1

Seoul, South Korea

Eisai Trial Site # 2

Seoul, South Korea

Eisai Trial Site # 3

Seoul, South Korea

Key Dates

Start Date

September 21, 2017

Primary Completion Date

January 16, 2020

Completion Date

January 16, 2020

Last Updated

March 10, 2020

Enrollment

ACTUAL participants

Conditions

Inflammatory Bowel Disease

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Inflammatory Bowel DiseasesCrohn's Disease

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RECRUITINGNA

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Inflammatory Bowel Disease

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

Impact of Morning Light Therapy in IBD

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

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