Gut Permeability, Sensitivity and Symptomatology

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

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

Conditions
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Irritable Bowel Syndrome, Visceral Hypersensitivity

Intervention / Treatment
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* Procedure: Gastrointestinal Permeability Test
* Procedure: Upper Endoscopy
* Procedure: Rectal Barostat and Infusion of Fats


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Healthy Volunteers<br>Participants will receive a Gastrointestinal Permeability Test, Upper Endoscopy, Rectal Barostat and Infusion of Fats. | Procedure: Gastrointestinal Permeability Test<br>* This test will involve ingesting a solution followed by urinalysis<br>Procedure: Upper Endoscopy<br> <br> Procedure: Rectal Barostat and Infusion of Fats<br>* Feeding tube will be placed, as well as a small balloon in the rectum.<br>|
| Experimental: Irritable Bowel Syndrome Patients<br>Participants will receive a Gastrointestinal Permeability Test, Upper Endoscopy, Rectal Barostat and Infusion of Fats. | Procedure: Gastrointestinal Permeability Test<br>* This test will involve ingesting a solution followed by urinalysis<br>Procedure: Upper Endoscopy<br> <br> Procedure: Rectal Barostat and Infusion of Fats<br>* Feeding tube will be placed, as well as a small balloon in the rectum.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent of complete epithelial cell loss |  | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBS, Irritable Bowel Syndrome, Visceral Hypersensitivity, Permeability, Small Bowel, Lactulose, Mannitol