An interventional study of Confocal Laser Endomicroscopy in Irritable Bowel Syndrome and Food Allergy, sponsored by Cook Children's Health Care System. Not yet recruiting. Open to participants aged 2 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-02-24.
Sponsored by Cook Children's Health Care System · Not applicable, Interventional, and Diagnostic
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.
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.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's planned enrollment of 200 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Cook Children's Health Care System is the lead sponsor of 11 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients must meet all of the following criteria to be included in the study
Exclusion Criteria:
CLE will be used to observe changes in the duodenal mucosa once the allergen is introduced.
Device: 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.
Number of subjects with IBS symptoms with evidence of epithelial barrier dysfunction
Time frame: Day 1
Health-Related Quality of Life as Assessed by Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Scale Questionnaire
The Pediatric Quality of Life Inventory (PedsQL) Questionnaire is an instrument used to measure quality of life in children and adolescents ages 2-18 that can be used by children to self-report or by parents as a proxy. PedsQL Gastrointestinal Symptoms Scales is a specific module of the PedsQL containing 58 items across 10 gastrointestinal symptom scales. Participants rate problems on a scale of 0 (never a problem) to 4 (almost always a problem). Items are reverse-scored and linearly transformed to a 0-100 scale, thus higher scores indicate better GI-specific Health-Related Quality of Life (HRQOL) and hence lower symptoms.
Time frame: Baseline, 1 month, 6 months, 12 months
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Cook Children's Health Care System