Endomicroscopic Evaluation of Food-induced Gastrointestinal Mucosal Alteration

NCT06792838 | Not Yet Recruiting

• 1 other identifier: 2024-073
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Irritable Bowel Syndrome; Food Allergy

Outcome Measures

Primary Outcomes (1)

• Number of subjects with IBS symptoms with evidence of epithelial barrier dysfunction

  Day 1

Secondary Outcomes (1)

• Health-Related Quality of Life as Assessed by Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Scale Questionnaire

  Baseline, 1 month, 6 months, 12 months

Study Arms (1)

Patients with IBS

EXPERIMENTAL

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

Device: Confocal Laser Endomicroscopy

Interventions

Confocal Laser Endomicroscopy 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.

Patients with IBS

Eligibility Criteria

• Age: 2 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cook Children's Health Care System: lead
• University of Nebraska Medical Center and Children's Hospital & Medical Center: collaborator
• Stanford University: collaborator
• Metrodora Institute: collaborator
• Meliora Bio ApS: collaborator

Related Publications (8)

• Bilaver LA, Thivalapill N, Zaslavsky J, Galic I, Gupta RS, Nimmagadda SR. Prevalence and correlates of co-occurring allergies in a US food allergy patient registry. J Allergy Clin Immunol Pract. 2023 Jan;11(1):332-334.e1. doi: 10.1016/j.jaip.2022.10.006. Epub 2022 Oct 19. No abstract available.

  PMID: 36272719 BACKGROUND

• Buchner AM, Wallace MB. Endomicroscopy and Molecular Tools to Evaluate Inflammatory Bowel Disease. Gastrointest Endosc Clin N Am. 2016 Oct;26(4):657-68. doi: 10.1016/j.giec.2016.06.002. Epub 2016 Aug 16.

  PMID: 27633594 BACKGROUND

• Shavrov A, Kharitonova AY, Davis EM, Claggett B, Morozov DA, Brown DK, Shavrov AA, Liu JJ. A Pilot Study of Confocal Laser Endomicroscopy to Predict Barrier Dysfunction and Relapse in Pediatric Inflammatory Bowel Disease. J Pediatr Gastroenterol Nutr. 2016 Jun;62(6):873-8. doi: 10.1097/MPG.0000000000001022.

  PMID: 26513619 BACKGROUND

• Fritscher-Ravens A, Schuppan D, Ellrichmann M, Schoch S, Rocken C, Brasch J, Bethge J, Bottner M, Klose J, Milla PJ. Confocal endomicroscopy shows food-associated changes in the intestinal mucosa of patients with irritable bowel syndrome. Gastroenterology. 2014 Nov;147(5):1012-20.e4. doi: 10.1053/j.gastro.2014.07.046. Epub 2014 Jul 30.

  PMID: 25083606 BACKGROUND

• Turcotte JF, Kao D, Mah SJ, Claggett B, Saltzman JR, Fedorak RN, Liu JJ. Breaks in the wall: increased gaps in the intestinal epithelium of irritable bowel syndrome patients identified by confocal laser endomicroscopy (with videos). Gastrointest Endosc. 2013 Apr;77(4):624-30. doi: 10.1016/j.gie.2012.11.006. Epub 2013 Jan 26.

  PMID: 23357497 BACKGROUND

• Rath T, Dieterich W, Katscher-Murad C, Neurath MF, Zopf Y. Cross-sectional imaging of intestinal barrier dysfunction by confocal laser endomicroscopy can identify patients with food allergy in vivo with high sensitivity. Sci Rep. 2021 Jun 17;11(1):12777. doi: 10.1038/s41598-021-92262-4.

  PMID: 34140591 BACKGROUND

• Fritscher-Ravens A, Pflaum T, Mosinger M, Ruchay Z, Rocken C, Milla PJ, Das M, Bottner M, Wedel T, Schuppan D. Many Patients With Irritable Bowel Syndrome Have Atypical Food Allergies Not Associated With Immunoglobulin E. Gastroenterology. 2019 Jul;157(1):109-118.e5. doi: 10.1053/j.gastro.2019.03.046. Epub 2019 May 15.

  PMID: 31100380 BACKGROUND

• Ray K. Endoscopy: a window into the gut--real-time visualization of the effects of food intolerance using confocal laser endomicroscopy. Nat Rev Gastroenterol Hepatol. 2014 Oct;11(10):578. doi: 10.1038/nrgastro.2014.147. Epub 2014 Aug 19. No abstract available.

  PMID: 25134512 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome; Food Hypersensitivity

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Clifton Huang, MD

  Cook Children's Health Care System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sumith Roy, MBBS, MPH

CONTACT

682-885-1790; Sumith.Roy@cookchildrens.org

Laurie Bailey, PhD

CONTACT

682-885-6451; Laurie.Bailey@cookchildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 27, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): September 1, 2033
• Study Completion (Estimated): September 1, 2034
• Last Updated: February 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share