Biomarkers for Intestinal Permeability in Patients With Constipation

Mayo Clinic

Status: Completed

Conditions: Irritable Bowel Syndrome; Intestinal Diseases; Constipation

Treatments: Procedure: Flexible sigmoidoscopy; Diagnostic Test: Permeability measurement; Procedure: Esophagogastroduodenoscopy

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02246647

14-002382

Details and patient eligibility

About

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).

Full 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, differences in small intestinal and colonic mucosal barrier function, differences in effects of fecal supernatants on barrier function of T84 monolayers, and differences in novel biomarkers for intestinal permeability

Enrollment: 39 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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 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

Trial design

39 participants in 2 patient groups

Healthy volunteers

Description:

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

Treatment:

Procedure: Flexible sigmoidoscopy

Diagnostic Test: Permeability measurement

Procedure: Esophagogastroduodenoscopy

IBS-C

Description:

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

Treatment:

Procedure: Flexible sigmoidoscopy

Diagnostic Test: Permeability measurement

Procedure: Esophagogastroduodenoscopy