Gut Permeability, Sensitivity and Symptomatology (GPSS)

September 2, 2021 updated by: Madhusudan (Madhu) Grover, MBBS, Mayo Clinic

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Percent of complete epithelial cell loss
Time Frame: 72 hours
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

University of Erlangen-Nürnberg
University of Leeds
Heidelberg University

Investigators

  • Principal Investigator: Madhusudan Grover, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

March 11, 2021

Study Completion (Actual)

March 11, 2021

Study Registration Dates

First Submitted

January 30, 2015

First Submitted That Met QC Criteria

February 3, 2015

First Posted (Estimate)

February 9, 2015

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

September 2, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-000837

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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