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

NCT ID: NCT03264690

Last Updated: 2020-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-21

Study Completion Date

2020-01-16

Brief Summary

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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

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Conditions

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Inflammatory Bowel Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Microbial composition measured from IBD and non-IBD groups

Participants with inflammatory bowel disease (IBD) and non-IBD will be measured for microbial composition.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eisai Korea Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Eisai Trial Site # 1

Seoul, , South Korea

Site Status

Eisai Trial Site # 2

Seoul, , South Korea

Site Status

Eisai Trial Site # 3

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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D2E7-M082-602

Identifier Type: -

Identifier Source: org_study_id

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