Endomicroscopic Evaluation of Food-induced Gastrointestinal Mucosal Alteration

Launched by COOK CHILDREN'S HEALTH CARE SYSTEM · Jan 23, 2025

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ClinConnect Summary

This clinical trial is investigating how certain foods can affect the lining of the gastrointestinal (GI) tract in people with ongoing symptoms similar to Irritable Bowel Syndrome (IBS). The researchers aim to create a new registry in the U.S. to gather information on these changes by using a special imaging technique called Confocal Laser Endomicroscopy (CLE). This study is focused on both adults and children who have IBS-like symptoms but test negative for celiac disease and have low levels of food allergies.

To be eligible for this trial, participants must have a long history of IBS-like symptoms related to food and have negative tests for food allergies and celiac disease. However, individuals with certain health conditions, such as inflammatory bowel disease or active gastrointestinal bleeding, cannot participate. If you join the study, you can expect to undergo a procedure that uses CLE to examine your GI tract after eating specific foods. This could help researchers learn more about how food affects people with these symptoms and improve future treatments.

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Eligibility criteria

• 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.