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Mucosal Innate Immune Activation in Chronic Intestinal Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03529318
Recruitment Status : Withdrawn (Lack of funding)
First Posted : May 18, 2018
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Irritable Bowel Syndrome Inflammatory Bowel Diseases Procedure: Biopsies from endoscopy

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Mucosal Innate Immune Activation in Chronic Intestinal Disorders
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : October 18, 2019
Estimated Study Completion Date : October 18, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy


Intervention Details:
  • 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".


Primary Outcome Measures :
  1. The number of specimens showing elevated levels of mucosal innate immune activation [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529318


Locations
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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
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Principal Investigator: Benjamin Tharian, MD University of Arkansas
Principal Investigator: Julia Liu, MD University of Arkansas
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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT03529318    
Other Study ID Numbers: 217718
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Irritable Bowel Syndrome
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Colonic Diseases, Functional
Colonic Diseases