Biomarkers for Intestinal Permeability in Patients With Constipation

Overview

About this study

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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  1. 18 - 65 years old
  2. IBS-C by Rome III criteria (for IBS-C participants)
  3. No abdominal surgery (except appendectomy and cholecystectomy)

Exclusion Criteria:

  1. History of Inflammatory Bowel Disease (IBD) , microscopic colitis or celiac disease
  2. Use of tobacco products within the past 6 months
  3. Use of NSAIDs or aspirin within the past week
  4.  Use of oral corticosteroids within the previous 6 weeks
  5. 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
  6. 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
      1. Anti-nausea agents (e.g, trimethobenzamide, promethazine, prochlorperazine, dimenhydrinate, hydroxyzine)
      2. Osmotic laxative agents (e.g, lactulose, sorbitol or PEG solutions as Miralax and Glycolax)
      3. Prokinetic agents (e.g, cisapride, metoclopramide, itopride, domperidone)
  7. Antimuscarinics
  8. Peppermint oil
  9. Systemic antibiotics, rifaximin, metronidazole.
  10. Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies
  11. Score > 8 for anxiety or depression on Hospital anxiety and depression scale.
  12. Pregnancy

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Madhusudan Grover, M.B.B.S.

Closed for enrollment

More information

Publications

Publications are currently not available
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CLS-20119079

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