Gut Permeability, Sensitivity and Symptomatology

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02358564

Acronym

GPSS

Enrollment

Registered

2015-02-09

Start date

2015-02-28

Completion date

2021-03-11

Last updated

2021-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome, Visceral Hypersensitivity

Keywords

IBS, Irritable Bowel Syndrome, Visceral Hypersensitivity, Permeability, Small Bowel, Lactulose, Mannitol

Brief summary

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

Interventions

PROCEDUREGastrointestinal Permeability Test

This test will involve ingesting a solution followed by urinalysis

PROCEDUREUpper Endoscopy

PROCEDURERectal Barostat and Infusion of Fats

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Mean Percent of complete epithelial cell loss	72 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026