Mucosal Innate Immune Activation in Chronic Intestinal Disorders

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.

Study Overview

• Status: Withdrawn
• Conditions: Irritable Bowel Syndrome; Inflammatory Bowel Diseases
• Intervention / Treatment: Procedure: Biopsies from endoscopy

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The subject population includes patients with known Crohn's disease, ulcerative colitis and indeterminant colitis. Patients will be recruited after they check in to the endoscopy unit, and before their endoscopic procedure, prior to any pre-procedure sedation medications having been given. All participants are undergoing endoscopy with biopsy for surveillance, screening, , diagnosis , or assessment of treatment. If no biopsy specimens are taken from subjects for diagnosis, no biopsy samples are taken for research purposes. The subject enrollment goal is 60 separate subjects with Crohn's disease, ulcerative colitis and indeterminant colitis or Irritable bowel syndrome. The subjects' participation will be limited to in the endoscopy suite.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of specimens showing elevated levels of mucosal innate immune activation	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.	Up to 2 years

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Principal Investigator: Benjamin Tharian, MD, University of Arkansas; Principal Investigator: Julia Liu, MD, University of Arkansas

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): October 18, 2019
• Study Completion (Anticipated): October 18, 2019

Study Registration Dates

• First Submitted: May 7, 2018
• First Submitted That Met QC Criteria: May 7, 2018
• First Posted (Actual): May 18, 2018

Study Record Updates

• Last Update Posted (Actual): October 22, 2019
• Last Update Submitted That Met QC Criteria: October 18, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases, Functional; Colonic Diseases; Irritable Bowel Syndrome; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: 217718

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No