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Gut Permeability, Sensitivity and Symptomatology (GPSS)

Primary Purpose

Irritable Bowel Syndrome, Visceral Hypersensitivity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gastrointestinal Permeability Test
Upper Endoscopy
Rectal Barostat and Infusion of Fats
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Irritable Bowel Syndrome focused on measuring IBS, Irritable Bowel Syndrome, Visceral Hypersensitivity, Permeability, Small Bowel, Lactulose, Mannitol

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mayo Clinic in Florida
  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Healthy Volunteers

Irritable Bowel Syndrome Patients

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mean Percent of complete epithelial cell loss

Secondary Outcome Measures

Full Information

First Posted
January 30, 2015
Last Updated
September 2, 2021
Sponsor
Mayo Clinic
Collaborators
University of Erlangen-Nürnberg, Heidelberg University, University of Leeds
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1. Study Identification

Unique Protocol Identification Number
NCT02358564
Brief Title
Gut Permeability, Sensitivity and Symptomatology
Acronym
GPSS
Official Title
Gut Permeability, Sensitivity and Symptomatology: Is There a Link and Explanation for Exacerbation of Symptoms Post Meals
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
March 11, 2021 (Actual)
Study Completion Date
March 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
University of Erlangen-Nürnberg, Heidelberg University, University of Leeds

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Visceral Hypersensitivity
Keywords
IBS, Irritable Bowel Syndrome, Visceral Hypersensitivity, Permeability, Small Bowel, Lactulose, Mannitol

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Volunteers
Arm Type
Active Comparator
Arm Description
Participants will receive a Gastrointestinal Permeability Test, Upper Endoscopy, Rectal Barostat and Infusion of Fats.
Arm Title
Irritable Bowel Syndrome Patients
Arm Type
Experimental
Arm Description
Participants will receive a Gastrointestinal Permeability Test, Upper Endoscopy, Rectal Barostat and Infusion of Fats.
Intervention Type
Procedure
Intervention Name(s)
Gastrointestinal Permeability Test
Intervention Description
This test will involve ingesting a solution followed by urinalysis
Intervention Type
Procedure
Intervention Name(s)
Upper Endoscopy
Intervention Type
Procedure
Intervention Name(s)
Rectal Barostat and Infusion of Fats
Intervention Description
Feeding tube will be placed, as well as a small balloon in the rectum.
Primary Outcome Measure Information:
Title
Mean Percent of complete epithelial cell loss
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madhusudan Grover, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Gut Permeability, Sensitivity and Symptomatology

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