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Mucosal Innate Immune Activation in Chronic Intestinal Disorders

Mucosal Innate Immune Activation in Chronic Intestinal Disorders

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03529318
Enrollment
0
Registered
2018-05-18
Start date
2018-09-01
Completion date
2019-10-18
Last updated
2019-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases, Irritable Bowel Syndrome

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.

Interventions

PROCEDUREBiopsies 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.

Sponsors

University of Arkansas
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The number of specimens showing elevated levels of mucosal innate immune activationUp to 2 yearsDetermining 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026