Non-Celiac Gluten Sensitivity Clinical Trial
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 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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | January 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Digestive Health Clinic Research | Richmond Hill | Ontario |
Lead Sponsor | Collaborator |
---|---|
Exzell Pharma Inc. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | No |
Secondary | Adverse event assessment | The incidence and severity of adverse events. | Baseline to 7 days. | No |
Secondary | 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. | No |
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