Status:
COMPLETED
Biomarkers for Intestinal Permeability in Patients With Constipation
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Takeda Pharmaceuticals International, Inc.
Conditions:
Intestinal Diseases
Irritable Bowel Syndrome
Eligibility:
FEMALE
18-65 years
Brief Summary
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 biom...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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 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
Exclusion
Key Trial Info
Start Date :
September 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 8 2016
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT02246647
Start Date
September 1 2014
End Date
December 8 2016
Last Update
August 21 2019
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905