Non-Celiac Gluten Sensitivity
Conditions
Keywords
gluten, non-celiac, gluten sensitivity
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).
Interventions
OTHERProbiotic ES1
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.
OTHERPlacebo
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.
Sponsors
Exzell Pharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean overall symptoms (as assessed by a 100-mm visual analog scale) in active versus placebo. | Baseline to 7 days. | The efficacy of Probiotic ES1 using a 100-mm visual analog scale (VAS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event assessment | Baseline to 7 days. | The incidence and severity of adverse events. |
| Change in individual symptoms (as assessed by a 100-mm VAS) in active versus placebo. | Baseline to 7 days. | The efficacy of Probiotic ES1 using a 100-mm visual analog scale (VAS). |
Countries
Canada
Contacts
Primary ContactMakayla Tosh, BSc.
Outcome results
None listed