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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Non-Celiac Gluten Sensitivity

Intervention / Treatment
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* Other: Probiotic ES1
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (Probiotic ES1)<br>Capsules containing 1 billion CFU of B. longum ES1 per capsule. One capsule taken before and after consuming 2 slices of bread for 7 days. | Other: Probiotic ES1<br>* 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.<br>* Other names: Glutagest;|
| Placebo Comparator: Placebo<br>Capsules not containing the active ingredient B. longum ES1. One capsule taken before and after consuming 2 slices of bread for 7 days. | Other: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gluten, non-celiac, gluten sensitivity