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Clinical Trials/NCT02810301
NCT02810301UnknownPhase 2

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

Exzell Pharma Inc.2 sites in 1 country60 target enrollmentStarted: April 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Sponsor
Enrollment
60
Locations
2
Primary Endpoint
Change in mean overall symptoms (as assessed by a 100-mm visual analog scale) in active versus placebo.

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Change in mean overall symptoms (as assessed by a 100-mm visual analog scale) in active versus placebo.

Time Frame: Baseline to 7 days.

The efficacy of Probiotic ES1 using a 100-mm visual analog scale (VAS).

Secondary Outcomes

  • Change in individual symptoms (as assessed by a 100-mm VAS) in active versus placebo.(Baseline to 7 days.)
  • Adverse event assessment(Baseline to 7 days.)

Investigators

Sponsor
Exzell Pharma Inc.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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