Gut Permeability, Sensitivity and Symptomatology

Irritable Bowel Syndrome Clinical Trial

— GPSS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02358564
• Other study ID #: 14-000837
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: March 11, 2021

Study information

• Verified date: September 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 11, 2021
• Est. primary completion date: March 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypersensitivity
• Irritable Bowel Syndrome
• Visceral Hypersensitivity

Intervention

Procedure:
• Gastrointestinal Permeability Test
This test will involve ingesting a solution followed by urinalysis
• Upper Endoscopy

• Rectal Barostat and Infusion of Fats
Feeding tube will be placed, as well as a small balloon in the rectum.

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
Mayo Clinic	Heidelberg University, University of Erlangen-Nürnberg, University of Leeds

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Percent of complete epithelial cell loss		72 hours

External Links

•   Mayo Clinic Clinical Trials