Biomarkers for Intestinal Permeability in Patients With Constipation
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-002382
NCT ID: NCT02246647
Sponsor Protocol Number: 14-002382
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:
- 18 - 65 years old
- IBS-C by Rome III criteria (for IBS-C participants)
- No abdominal surgery (except appendectomy and cholecystectomy)
Exclusion Criteria:
- History of Inflammatory Bowel Disease (IBD) , microscopic colitis or celiac disease
- Use of tobacco products within the past 6 months
- Use of NSAIDs or aspirin within the past week
- Use of oral corticosteroids within the previous 6 weeks
- 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
- Ingestion of any prescription, over the counter, or herbal medications which can affect gastrointestinal transit 7 days before study begins
- Any treatment specifically taken for IBS, including loperamide, cholestyramine, alosetron
- Drugs with a known pharmacological activity at 5-HT4, 5-HT2b or 5-HT3 receptors (e.g, tegaserod, ondansetron, tropisetron, granisetron, dolasetron, mirtazapine);
- All narcotics (e.g, codeine, morphine, and propoxyphene, either alone or in combination)
- Anti-cholinergic agents (e.g, dicyclomine, hyoscyamine, propantheline)
- Ultram
- 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)
- Antimuscarinics
- Peppermint oil
- Systemic antibiotics, rifaximin, metronidazole.
- Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies
- Score > 8 for anxiety or depression on Hospital anxiety and depression scale.
- Pregnancy
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available