Biomarkers for Intestinal Permeability in Patients With Constipation
Completed
Conditions studied: Intestinal Diseases, Irritable Bowel Syndrome, Constipation
In brief
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).
Key facts
- Study ID
- NCT02246647
- Run by
- Mayo Clinic
- People needed
- 39
- Starts
- 2014-09-01
- Expected to finish
- 2016-12-08
- Last updated by the study team
- 2019-08-21
Who can join
Age: 18 and older, up to 65. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 18 - 65 years old
- IBS-C by Rome III criteria (for IBS-C participants)
- No abdominal surgery (except appendectomy and cholecystectomy)
You may not qualify if…
- 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 Splenda (sucralose), Nutrasweet (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
Where it is running
- Mayo Clinic in Rochester — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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