Mucosal Innate Immune Activation in Chronic Intestinal Disorders

Inflammatory Bowel Diseases Clinical Trial

Official title:

Mucosal Innate Immune Activation in Chronic Intestinal Disorders

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03529318
• Other study ID #: 217718
• Status: Withdrawn
• Start date: September 1, 2018
• Est. completion date: October 18, 2019

Study information

• Verified date: October 2019
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 18, 2019
• Est. primary completion date: October 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases
• Irritable Bowel Syndrome

Intervention

Procedure:
• 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".

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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