NCT05616429

Alcat Based Elimination Diet for the Treatment of Irritable Bowel Syndrome; a Randomized Double Blind Sham Control Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Diet therapies for IBS are becoming an important part of the treatment for patients with IBS \[Lenhart A et al, J Neurogastroenterology Motil 2018\] There are many types of elimination diets utilized by patients with IBS including personalized diets based upon mediator release testing and IgG (immunoglobulin G) antibody. These diets have the potential for tailor made personal diet but currently have little or no clinical evidence for efficacy. Diet therapies, like medical therapies for IBS, should be properly evaluated in appropriate designed clinical trials. It is also important to protect our patients with IBS from potentially ineffective, costly and unsafe intervention.

Conditions

• IBS - Irritable Bowel Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Alcat based personal diet	Alcat based personalized diet with dietician supervision and follow-up + usual care
DIETARY_SUPPLEMENT	Standard balanced diet	"Sham" standard balanced diet with dietician supervision and follow up + usual care.
OTHER	usual care	usual care

Timeline

• Start date: 2020-08-01
• Primary completion: 2023-05-15
• Completion: 2023-05-15
• First posted: 2022-11-15
• Last updated: 2023-05-23

Locations

1 site across 1 country: Israel