Endomicroscopic Evaluation of Food-induced Gastrointestinal Mucosal Alteration

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2034-09-30

Brief Summary

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The overarching goal of this study is to establish a first ever registry in the U.S. to collect outcomes data to evaluate changes in the gastrointestinal (GI) mucosa following direct food application utilizing Confocal Laser Endomicroscopy (CLE). This will be assessed in pediatric and adult patients who present to the outpatient clinic with persistent irritable bowel syndrome-like symptoms while testing negative for celiac disease and have either negative or very low/low levels of Immunoglobulin E (IgE) serological tests.

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Detailed Description

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The prevalence of food allergies in children and adults are estimated to be 5-7% and 11% in the US respectively. The mechanism underlying food allergies are either IgE mediated, non-IgE mediated or both.

CLE is a diagnostic modality that allows for high-resolution imaging of the GI tract, providing real-time in-vivo visualization of the mucosal and submucosal microstructure similar to histology. What differentiates it from conventional histology wherein tissue is sectioned vertically, is that the endomicroscopic images are a single optical plane parallel to the tissue surface, yielding multiple optical sections of successive depths of greater precision.

Recent studies demonstrated the utility of CLE in the evaluation of gastroenterological diseases, specifically for inflammatory bowel disease. Although histological evaluation continues to remain the gold standard, CLE has potential applications in surveillance, targeted biopsies and disease management of GI conditions such as celiac disease, eosinophilic disease and more recently in patients with Irritable Bowel Syndrome (IBS) with atypical food allergies that are non-IgE mediated.

A common observation in patients with IBS using CLE include increased epithelial gaps when compared to healthy controls. It is proposed that there is an alteration in the epithelial barrier which in healthy state, prevents the microbes and antigens from entering the body. Increased epithelial cell extrusions result in altered intestinal permeability, which is commonly seen in IBS. The utility of CLE in visualizing the integrity of the intestinal barrier in children with atypical presentation of food allergies is unknown. The ability to observe these dynamic changes in real-time is promising in the management of IBS.

Endomicroscopic diagnosis of food-induced allergy-like reactions was first used as a guideline in the implementation of the food intolerance testing performed as part of this protocol.

Conditions

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Irritable Bowel Syndrome Food Allergy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This study is not an interventional study; however, it uses an FDA approved investigational device.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with IBS

CLE will be used to observe changes in the duodenal mucosa once the allergen is introduced.

Group Type EXPERIMENTAL

Confocal Laser Endomicroscopy

Intervention Type DEVICE

1. The Endo microscope probe will be prepped in channel #1 and normal saline (30 ml) will be flushed into the duodenal mucosa through channel # 2 which will serve as a control. Inject 1-3ml fluorescein 10% intravenously.
2. The duodenal mucosa is assessed at a minimum of four sites (20 seconds each
3. The first potential allergen will be sprayed via catheter onto the mucosa.
4. After 2 minutes, three different areas of of duodenum will be assessed with the gastroflex probe for fluorescein leakage and cell shedding. If fluorescein leakage and cell shedding are visualized that is considered a positive test,no further allergy testing can be conducted. If the first allergen test is negative, irrigate and repeat steps for the next potential allergen for a maximum of three allergens per patient.

Interventions

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Confocal Laser Endomicroscopy

1. The Endo microscope probe will be prepped in channel #1 and normal saline (30 ml) will be flushed into the duodenal mucosa through channel # 2 which will serve as a control. Inject 1-3ml fluorescein 10% intravenously.
2. The duodenal mucosa is assessed at a minimum of four sites (20 seconds each
3. The first potential allergen will be sprayed via catheter onto the mucosa.
4. After 2 minutes, three different areas of of duodenum will be assessed with the gastroflex probe for fluorescein leakage and cell shedding. If fluorescein leakage and cell shedding are visualized that is considered a positive test,no further allergy testing can be conducted. If the first allergen test is negative, irrigate and repeat steps for the next potential allergen for a maximum of three allergens per patient.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Patients must meet all of the following criteria to be included in the study

* Adults and children presenting with a prolonged history of IBS-like symptoms (as described by Rome IV criteria) related to food intake.
* A negative or very low/low levels of Ig-E food allergy panel or negative skin prick test
* Negative celiac disease work up

Exclusion Criteria

* If patient had a previous Esophagogastroduodenoscopy (EGD) and Colonoscopy with biopsy positive for any chronic inflammatory condition for eg. Inflammatory Bowel Disease (IBD), the patient will be excluded.
* Pregnant or nursing at the time of CLE.
* Known allergy to fluorescein.
* Impaired renal function tests.
* Active GI bleeding.

Minimum Eligible Age

2 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No