Efficacy of Probiotic ES1 for the Treatment of Non-Celiac Gluten Sensitivity

Non-Celiac Gluten Sensitivity Clinical Trial

Official title: A Randomized, Double-Blind, Placebo-Controlled Study on the Efficacy of Bifidobacterium Longum Probiotic ES1 for the Treatment of Non-Celiac Gluten Sensitivity

Status Recruiting

Clinical Trial Summary

Study to demonstrate the efficacy of Probiotic ES1 in alleviating symptoms of gluten sensitivity in non-celiac gluten sensitive subjects exposed to a small, fixed amount of gluten.

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled study. Sixty non-celiac gluten sensitive subjects will be randomized into one of two groups; Probiotic ES1 or placebo. For the duration of the study, subjects must adhere to a gluten-free diet, apart from a scheduled fixed gluten exposure of two slices of bread once daily. Subjects will be required to take 1 capsule before and after consuming the two slices of bread and score the severity of their symptoms in a diary provided for the duration of the study (7 days). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypersensitivity
• Non-Celiac Gluten Sensitivity

• NCT number: NCT02810301
• Study type: Interventional
• Source: Exzell Pharma Inc.
• Contact: Makayla Tosh, BSc.
• Phone: 9057075007
• Email: mtosh@digestivehealth.ca
• Status: Recruiting
• Phase: Phase 2
• Start date: April 2016
• Completion date: January 2018