NCT02246647

Biomarkers for Intestinal Permeability in Patients With Constipation

Biomarkers for Intestinal Permeability in Patients With Functional Lower Gastrointestinal Disorders Associated With Constipation.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 39 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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 biomarkers for measuring intestinal permeability in patients with constipation predominant Irritable Bowel Syndrome (IBS-C).

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, 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

Conditions

• Intestinal Diseases
• Irritable Bowel Syndrome
• Constipation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Permeability measurement	Saccharide excretion was compared between IBS-C and healthy volunteers
PROCEDURE	Esophagogastroduodenoscopy	Duodenal biopsies were collected from IBS-C and healthy volunteers
PROCEDURE	Flexible sigmoidoscopy	Colonic biopsies were collected from IBS-C and healthy volunteers

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-12-08
• Completion: 2016-12-08
• First posted: 2014-09-23
• Last updated: 2019-08-21
• Results posted: 2019-08-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study