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Completed

NCT Number: NCT02358564

Gut Permeability, Sensitivity and Symptomatology

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

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Visceral Hypersensitivity

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida, Jacksonville, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gastrointestinal Permeability Test

Procedure

This test will involve ingesting a solution followed by urinalysis

Upper Endoscopy

Procedure

Rectal Barostat and Infusion of Fats

Procedure

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

Primary outcomes

  1. Mean Percent of complete epithelial cell loss

    Time frame: 72 hours

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Heidelberg University
  • University of Erlangen-Nürnberg
  • University of Leeds

Registry information

Official study title

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

Acronym: GPSS

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Feb 9, 2015
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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