Clinical trial NCT02810301: Efficacy of Probiotic ES1 for the Treatment of Non-Celiac Gluten Sensitivity
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-Celiac Gluten Sensitivity
Keywords: gluten
non-celiac
gluten sensitivity
Lead sponsor: Exzell Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in mean overall symptoms (as assessed by a 100-mm visual analog scale) in active versus placebo.
timeFrame: Baseline to 7 days.
Secondary outcomes:
measure: Adverse event assessment
timeFrame: Baseline to 7 days.
measure: Change in individual symptoms (as assessed by a 100-mm VAS) in active versus placebo.
timeFrame: Baseline to 7 days.
Other outcomes:
Locations:
city: Richmond Hill
country: Canada
facility: Digestive Health Clinic Research
state: Ontario
Study officials:
affiliation: Digestive Health Clinic / Exzell Pharma Inc.
name: Dr. Pardeep Nijhawan, MD
role: PRINCIPAL_INVESTIGATOR
References: