MedTrace Logo

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

NCT02810301 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-10-07

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Exzell Pharma Inc.

    lead INDUSTRY

Principal Investigators

  • Dr. Pardeep Nijhawan, MD · Digestive Health Clinic / Exzell Pharma Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-12-31
Completion
2018-01-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02810301 on ClinicalTrials.gov