Mucosal Innate Immune Activation in Chronic Intestinal Disorders

Withdrawn

• Conditions: Irritable Bowel Syndrome; Inflammatory Bowel Diseases

• Registration Number: NCT03529318
• Lead Sponsor: University of Arkansas

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2018-05-07
• Study First Submitted QC: 2018-05-07
• Study First Posted: 2018-05-18
• Study Start: 2018-09-01
• Status Verified: 2019-10
• Primary Completion: 2019-10-18
• Study Completion: 2019-10-18
• Last Update Submitted: 2019-10-18
• Last Update Posted: 2019-10-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of specimens showing elevated levels of mucosal innate immune activation	Up to 2 years	Determining the level of mucosal innate immune activation by staining, organoid culture, Western blot analysis, and cytokine expression on biopsy samples in IBD and IBS patient samples.

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States