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