Gut Permeability, Sensitivity and Symptomatology

Not Applicable

Completed

• Conditions: Visceral Hypersensitivity; Irritable Bowel Syndrome
• Interventions: Procedure: Gastrointestinal Permeability Test; Procedure: Upper Endoscopy; Procedure: Rectal Barostat and Infusion of Fats

• Registration Number: NCT02358564
• Lead Sponsor: Mayo Clinic

Brief Summary

To better understand the relationship between gut barrier function and the symptomatology and pathophysiology of irritable bowel syndrome (IBS).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-30
• Study Start: 2015-02
• Study First Submitted QC: 2015-02-03
• Study First Posted: 2015-02-09
• Primary Completion: 2021-03-11
• Study Completion: 2021-03-11
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	Rectal Barostat and Infusion of Fats	Participants will receive a Gastrointestinal Permeability Test, Upper Endoscopy, Rectal Barostat and Infusion of Fats.
Irritable Bowel Syndrome Patients	Upper Endoscopy	Participants will receive a Gastrointestinal Permeability Test, Upper Endoscopy, Rectal Barostat and Infusion of Fats.
Healthy Volunteers	Gastrointestinal Permeability Test	Participants will receive a Gastrointestinal Permeability Test, Upper Endoscopy, Rectal Barostat and Infusion of Fats.
Healthy Volunteers	Upper Endoscopy	Participants will receive a Gastrointestinal Permeability Test, Upper Endoscopy, Rectal Barostat and Infusion of Fats.
Irritable Bowel Syndrome Patients	Rectal Barostat and Infusion of Fats	Participants will receive a Gastrointestinal Permeability Test, Upper Endoscopy, Rectal Barostat and Infusion of Fats.
Irritable Bowel Syndrome Patients	Gastrointestinal Permeability Test	Participants will receive a Gastrointestinal Permeability Test, Upper Endoscopy, Rectal Barostat and Infusion of Fats.

Primary Outcome Measures

Name	Time	Method
Mean Percent of complete epithelial cell loss	72 hours

Trial Locations

Locations (2)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States