GPSS: Gut Permeability, Sensitivity and Symptomatology

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT02358564

Collaborator

University of Erlangen-Nürnberg (Other), Heidelberg University (Other), University of Leeds (Other)

Enrollment

Locations

Arms

73.3

Duration (Months)

19.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel Syndrome Visceral Hypersensitivity	Procedure: Gastrointestinal Permeability Test Procedure: Upper Endoscopy Procedure: Rectal Barostat and Infusion of Fats	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Gut Permeability, Sensitivity and Symptomatology: Is There a Link and Explanation for Exacerbation of Symptoms Post Meals

Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Mar 11, 2021

Actual Study Completion Date :

Mar 11, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Healthy Volunteers Participants will receive a Gastrointestinal Permeability Test, Upper Endoscopy, Rectal Barostat and Infusion of Fats.	Procedure: Gastrointestinal Permeability Test This test will involve ingesting a solution followed by urinalysis Procedure: Upper Endoscopy Procedure: Rectal Barostat and Infusion of Fats Feeding tube will be placed, as well as a small balloon in the rectum.
Experimental: Irritable Bowel Syndrome Patients Participants will receive a Gastrointestinal Permeability Test, Upper Endoscopy, Rectal Barostat and Infusion of Fats.	Procedure: Gastrointestinal Permeability Test This test will involve ingesting a solution followed by urinalysis Procedure: Upper Endoscopy Procedure: Rectal Barostat and Infusion of Fats Feeding tube will be placed, as well as a small balloon in the rectum.

Arm

Intervention/Treatment

Active Comparator: Healthy Volunteers

Participants will receive a Gastrointestinal Permeability Test, Upper Endoscopy, Rectal Barostat and Infusion of Fats.

Procedure: Gastrointestinal Permeability Test

This test will involve ingesting a solution followed by urinalysis

Procedure: Upper Endoscopy

Procedure: Rectal Barostat and Infusion of Fats

Feeding tube will be placed, as well as a small balloon in the rectum.

Experimental: Irritable Bowel Syndrome Patients

Participants will receive a Gastrointestinal Permeability Test, Upper Endoscopy, Rectal Barostat and Infusion of Fats.

Procedure: Gastrointestinal Permeability Test

This test will involve ingesting a solution followed by urinalysis

Procedure: Upper Endoscopy

Procedure: Rectal Barostat and Infusion of Fats

Feeding tube will be placed, as well as a small balloon in the rectum.

Outcome Measures

Primary Outcome Measures

Mean Percent of complete epithelial cell loss [72 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion criteria

Age 18 to 70 years
No abdominal surgery (except appendectomy, cholecystectomy, hernia repair, hysterectomy, and C-section).
Written informed consent

Exclusion criteria

Females who are pregnant or breastfeeding
Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)
Use of NSAIDs or aspirin within the past week (since NSAIDs affect intestinal permeability)
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 tests begins, e.g. foods to be avoided are sugarless gyms or mints and diet soda.
Ingestion of any prescription, over the counter, or herbal medications which can affect gastrointestinal transit 7 days before the study begins.
Proton pump inhibitors.
Antibiotics for the preceding 60 days before the start of the study.
(vii) Alcohol intake beyond the recommended safe limit (<21 unites per week)
Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies.
Known allergy to fluorescein
Inflammatory bowel diseases, celiac disease.