Gut Permeability, Sensitivity and Symptomatology (GPSS)

Mayo Clinic

Status: Completed

Conditions: Visceral Hypersensitivity; Irritable Bowel Syndrome

Treatments: Procedure: Gastrointestinal Permeability Test; Procedure: Rectal Barostat and Infusion of Fats; Procedure: Upper Endoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02358564

14-000837

Details and patient eligibility

About

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

Enrollment: 39 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

Healthy Volunteers

Active Comparator group

Description:

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

Treatment:

Procedure: Upper Endoscopy

Procedure: Rectal Barostat and Infusion of Fats

Procedure: Gastrointestinal Permeability Test

Irritable Bowel Syndrome Patients

Experimental group

Description:

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

Treatment:

Procedure: Upper Endoscopy

Procedure: Rectal Barostat and Infusion of Fats

Procedure: Gastrointestinal Permeability Test