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

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.