Mucosal Innate Immune Activation in Chronic Intestinal Disorders

NCT ID: NCT03529318

Last Updated: 2019-10-22

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-10-18

Brief Summary

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Crohn's disease and ulcerative colitis are types of chronic intestinal disorder called inflammatory bowel diseases (IBD) that can affect the small and large bowel causing symptoms of abdominal pain, diarrhea, blood in the stool, and weight loss. Irritable bowel syndrome (IBS) is a milder form of IBD, with symptoms of abdominal pain, bloating, diarrhea or constipation, and blood in the stool. It is not known what causes diseases such as IBD and IBS. This study will look at the events in the gut that leads to leaky gut and inflammation in patients with IBD and IBS. The study will also see if medications such as rifaximin and mesalamine may reduce the amount of leaky gut.

Detailed Description

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Conditions

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Irritable Bowel Syndrome Inflammatory Bowel Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Biopsies from endoscopy

1\) Patients scheduled for endoscopy (EGD or colonoscopy) for IBD will be consented to allow physicians who are performing endoscopies to take additional biopsies and blood samples for "research purposes".

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Men and women, 18-years old and older
* Presenting at the University of Arkansas for Medical Sciences (UAMS) Endoscopy center to undergo endoscopy with biopsy for surveillance, screening or diagnosis.

Exclusion Criteria

* Subjects classified in an anesthesia risk group , American Society of Anesthesiologists Class (ASA) ≥ 4,
* history of bleeding diathesis or coagulopathy
* stroke or transient neurological attack within the last 6 months
* pregnancy
* currently on blood thinners (excepting aspirin)
* subject is unable to consent themselves
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benjamin Tharian, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Julia Liu, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

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University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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217718

Identifier Type: -

Identifier Source: org_study_id

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