Alcat Based Elimination Diet for the Treatment of Irritable Bowel Syndrome; a Randomized Double Blind Sham Control Trial - Trial NCT05616429
Access comprehensive clinical trial information for NCT05616429 through Pure Global AI's free database. This phase not specified trial is sponsored by Sheba Medical Center and is currently Recruiting. The study focuses on IBS - Irritable Bowel Syndrome. Target enrollment is 100 participants.
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Study Focus
Sponsor & Location
Sheba Medical Center
Timeline & Enrollment
N/A
Aug 01, 2020
Aug 01, 2023
Primary Outcome
Irritable Bowel Syndrome (IBS) Symptom Severity Scale questionnaire
Summary
Irritable bowel syndrome (IBS) is the most common GI condition with global prevalence ranging
 between 10-20%. Although the exact cause is not known there are increasing insights
 concerning the possible multifactorial etiology including low grade inflammation,
 neuromodulation, dysbiosis, impaired integrity of the intestinal barrier and more.
 
 Currently, it is believed that changes in the microbiota may activate mucosal innate immune
 responses, resulting in increased epithelial permeability, activated nociceptive sensory
 pathways, and dysregulation of the enteric nervous system.
 
 Nearly two thirds of patients with IBS perceive their GI symptoms to be food related, hence,
 food intolerance may be important factor in the pathogenesis. Diet is a part of IBS treatment
 but adherence, on the one hand, and restriction, on the other, remain a major problem. [Chey
 WD, Am J Gastroenterol,2016].
 
 Confocal laser endomicroscopy (CLE) is a technique that permits real-time detection and
 quantification of changes in intestinal tissues and cells, including increases in
 intraepithelial lymphocytes and fluid extravasation through epithelial leaks.
 
 Based on CLE analysis of IBS patients with a suspected food intolerance, exposure to
 candidate food antigens caused immediate breaks, increased intervillous spaces, and increased
 IELs in the intestinal mucosa. These changes are associated with patient responses to
 exclusion diets. [Fritscher-Ravens A et al, Gastroenterology. 2019, Gastroenterology. 2014]
 This technic, also efficient according to former studies, is costly and invasive.
 
 The Alcat Test is a lab based immune stimulation test in which a patient's WBC's (white blood
 cell) are challenged with various substances including foods, additives, colorings,
 chemicals, medicinal herbs, functional foods, molds and pharmaceutical compounds. The Alcat
 Test objectively classifies a patient's response to each test substance as reactive,
 borderline or non-reactive. Based on these classifications, a customized elimination/rotation
 diet may be designed.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05616429
Non-Device Trial