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

PHASE2UnknownINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

April 30, 2016

Primary Completion Date

December 31, 2017

Study Completion Date

January 31, 2018

Conditions
Non-Celiac Gluten Sensitivity
Interventions
OTHER

Probiotic ES1

B. longum ES1 is formulated for oral use as Glutagest. Each capsule contains 1 billion CFU of B. longum. The capsules are off-white in color and cylindrical in shape with approximate dimensions of 19 mm x 6.63 mm and a weight of 500 mg. Non-medicinal ingredients consist of the common excipients filler rice maltodextrin, lubricant stearic acid, and encapsulating agent vegetable cellulose.

OTHER

Placebo

The placebo is composed of the same non-medicinal ingredients as the investigational product (IP) (i.e. rice maltodextrin, stearic acid, and vegetable cellulose) but it does not contain the active ingredient B. longum ES1. The placebo is designed to resemble the IP in terms of physical appearance.

Trial Locations (1)

L9T2H4

RECRUITING

Digestive Health Clinic Research, Richmond Hill

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Exzell Pharma Inc.

INDUSTRY