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

Phase 2

• Conditions: Non-Celiac Gluten Sensitivity

• Registration Number: NCT02810301
• Lead Sponsor: Exzell Pharma Inc.

Brief 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.

Detailed 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 Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-06-17
• Study First Submitted QC: 2016-06-20
• Study First Posted: 2016-06-22
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-06
• Last Update Posted: 2016-10-07
• Primary Completion: 2017-12
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age: 18-65
• Male or non-pregnant, non-lactating females.
• Documented or self-diagnosed gluten sensitivity that is well-controlled.
• Negative celiac serology to eliminate Celiac Disease at screening.
• Written informed consent prior to any screening procedure.
• Ability and willingness to comply with study requirements.
• Adherence to a gluten-free diet during period of the study and 1 week prior to the first dose.
• BMI < 35 kg/m2.

Exclusion Criteria

• History of diagnosis of Celiac Disease.
• Positive pregnancy test at screening.
• Positive HIV, Hepatitis, or Tuberculosis infection.
• History of substance abuse within last 5 years.
• Alcohol consumption of > 2 standard drink equivalents per day.
• Recent myocardial infarction within past 3 months, recent stroke within past 12 months, recent abdominal surgery within past 12 months, history of any malignancies and/or active treatment for a psychiatric disorder.
• Use of systemic biologics within 6 months of the study.
• Use of oral probiotics within 2 weeks of the study.
• Use of NSAIDS or aspirin within 7 days of the study.
• Use of immunosuppressants within 30 days of the study.
• Family history (first degree relative) of Celiac Disease.
• Received an investigational product within 1 month of study.
• History of digestive enzyme deficiencies.
• History of severe reactions to low doses of gluten/accidental exposure to gluten.
• History of wheat allergy (positive reactions to the skin-prick test or the IgE blood test).
• History of lactose, milk protein and/or FODMAP allergies.
• Subjects who have an immune-compromised condition.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in mean overall symptoms (as assessed by a 100-mm visual analog scale) in active versus placebo.	Baseline to 7 days.	The efficacy of Probiotic ES1 using a 100-mm visual analog scale (VAS).

Secondary Outcome Measures

Name	Time	Method
Change in individual symptoms (as assessed by a 100-mm VAS) in active versus placebo.	Baseline to 7 days.	The efficacy of Probiotic ES1 using a 100-mm visual analog scale (VAS).
Adverse event assessment	Baseline to 7 days.	The incidence and severity of adverse events.

Trial Locations

Locations (1)

Digestive Health Clinic Research; 🇨🇦 Richmond Hill, Ontario, Canada