Biomarkers for Intestinal Permeability in Patients With Constipation
NCT ID: NCT02246647
Last Updated: 2019-08-21
Study Results
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View full resultsBasic Information
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COMPLETED
39 participants
OBSERVATIONAL
2014-09-30
2016-12-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Healthy volunteers
Permeability measurement: Ingestion of saccharides {mannitol (regular, 12C) 100 mg, lactulose 1 g and labelled (13C mannitol) 100 mg} in 250ml of water Esophagogastroduodenoscopy Flexible sigmoidoscopy
Permeability measurement
Saccharide excretion was compared between IBS-C and healthy volunteers
Esophagogastroduodenoscopy
Duodenal biopsies were collected from IBS-C and healthy volunteers
Flexible sigmoidoscopy
Colonic biopsies were collected from IBS-C and healthy volunteers
IBS-C
Permeability measurement: Ingestion of saccharides (mannitol (regular, 12C) 100 mg, lactulose 1 g and labelled (13C mannitol) 100 mg} in 250ml of water Esophagogastroduodenoscopy Flexible sigmoidoscopy
Permeability measurement
Saccharide excretion was compared between IBS-C and healthy volunteers
Esophagogastroduodenoscopy
Duodenal biopsies were collected from IBS-C and healthy volunteers
Flexible sigmoidoscopy
Colonic biopsies were collected from IBS-C and healthy volunteers
Interventions
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Permeability measurement
Saccharide excretion was compared between IBS-C and healthy volunteers
Esophagogastroduodenoscopy
Duodenal biopsies were collected from IBS-C and healthy volunteers
Flexible sigmoidoscopy
Colonic biopsies were collected from IBS-C and healthy volunteers
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. IBS-C by Rome III criteria (for IBS-C participants)
3. No abdominal surgery (except appendectomy and cholecystectomy)
Exclusion Criteria
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 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
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
* 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.
7. Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies.
8. Score \> 8 for anxiety or depression on Hospital anxiety and depression scale.
9. Pregnancy
18 Years
65 Years
FEMALE
Yes
Sponsors
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Takeda Pharmaceuticals International, Inc.
INDUSTRY
Mayo Clinic
OTHER
Responsible Party
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Madhusudan (Madhu) Grover, MBBS
Principal Investigator
Principal Investigators
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Madhusudan Grover, MBBS
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Other Identifiers
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14-002382
Identifier Type: -
Identifier Source: org_study_id
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