Biomarkers for Intestinal Permeability in Patients With Constipation



Status:Recruiting
Conditions:Constipation, Irritable Bowel Syndrome (IBS), Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 65
Updated:10/14/2017
Start Date:September 2014
End Date:October 2017

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Biomarkers for Intestinal Permeability in Patients With Functional Lower Gastrointestinal Disorders Associated With Constipation.

Our overall objective with this study is firstly to provide a comprehensive assessment of
intestinal permeability, mucosal barrier function using existing biomarkers and secondly to
explore novel biomarkers for measuring intestinal permeability in patients with constipation
predominant Irritable Bowel Syndrome (IBS-C).

In order to determine the differences in permeability in IBS-C in comparison with healthy
volunteers, the following will be determined: differences in in vivo small intestinal and
colonic permeability, differences in small intestinal and colonic mucosal barrier function,
differences in effects of fecal supernatants on barrier function of T84 monolayers, and
differences in novel biomarkers for intestinal permeability

Inclusion criteria:

A. 18 - 65 years old B. IBS-C by Rome III criteria (for IBS-C participants) C. No abdominal
surgery (except appendectomy and cholecystectomy)

Exclusion criteria:

A. History of Inflammatory Bowel Disease (IBD) , microscopic colitis or celiac disease B.
Use of tobacco products within the past 6 months C. Use of NSAIDs or aspirin within the
past week D. Use of oral corticosteroids within the previous 6 weeks E. Ingestion of
artificial sweeteners such as SplendaTM (sucralose), Nutrasweet TM(aspartame), lactulose or
mannitol 2 days before the study begins, e.g., foods to be avoided are sugarless gums or
mints and diet soda F. Ingestion of any prescription, over the counter, or herbal
medications which can affect gastrointestinal transit 7 days before study begins

1. Any treatment specifically taken for IBS, including loperamide, cholestyramine,
alosetron

2. Drugs with a known pharmacological activity at 5-HT4, 5-HT2b or 5-HT3 receptors (e.g,
tegaserod, ondansetron, tropisetron, granisetron, dolasetron, mirtazapine);

3. All narcotics (e.g, codeine, morphine, and propoxyphene, either alone or in
combination)

4. Anti-cholinergic agents (e.g, dicyclomine, hyoscyamine, propantheline).

5. Ultram

6. GI preparations

- Anti-nausea agents (e.g, trimethobenzamide, promethazine, prochlorperazine,
dimenhydrinate, hydroxyzine)

- Osmotic laxative agents (e.g, lactulose, sorbitol or PEG solutions as Miralax and
Glycolax)

- Prokinetic agents (e.g, cisapride, metoclopramide, itopride, domperidone);

7. Antimuscarinics;

8. Peppermint oil;

9. Systemic antibiotics, rifaximin, metronidazole. G. Bleeding disorders or medications
that increase risk of bleeding from mucosal biopsies.

H. Score > 8 for anxiety or depression on Hospital anxiety and depression scale.

I. Pregnancy
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: Madhusudan Grover
Phone: 507-293-4234
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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