Gut Permeability, Sensitivity and Symptomatology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2021-03-11

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).

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Detailed Description

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Conditions

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Irritable Bowel Syndrome Visceral Hypersensitivity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Healthy Volunteers

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

Group Type ACTIVE_COMPARATOR

Gastrointestinal Permeability Test

Intervention Type PROCEDURE

This test will involve ingesting a solution followed by urinalysis

Upper Endoscopy

Intervention Type PROCEDURE

Rectal Barostat and Infusion of Fats

Intervention Type PROCEDURE

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

Irritable Bowel Syndrome Patients

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

Group Type EXPERIMENTAL

Gastrointestinal Permeability Test

Intervention Type PROCEDURE

This test will involve ingesting a solution followed by urinalysis

Upper Endoscopy

Intervention Type PROCEDURE

Rectal Barostat and Infusion of Fats

Intervention Type PROCEDURE

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

Interventions

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Gastrointestinal Permeability Test

This test will involve ingesting a solution followed by urinalysis

Intervention Type PROCEDURE

Upper Endoscopy

Intervention Type PROCEDURE

Rectal Barostat and Infusion of Fats

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

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes