Recruiting
Phase 2

Probiotic ES1

Sponsor:

Exzell Pharma Inc.

Code:

NCT02810301

Conditions

Non-Celiac Gluten Sensitivity

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Probiotic ES1

Placebo

Study Details

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.

Conditions

Non-Celiac Gluten Sensitivity

Study ID

NCT02810301

Start date

Apr, 2016

Status verified date

Oct, 2016

Completion date

Jan, 2018

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (Probiotic ES1)

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.

placebo comparator: Placebo

Capsules not containing the active ingredient B. longum ES1. One capsule taken before and after consuming 2 slices of bread for 7 days.

Interventions

Probiotic 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.

Placebo

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.

Primary outcome measure

  • Change in mean overall symptoms (as assessed by a 100-mm visual analog scale) in active versus placebo. [ Time Frame: Baseline to 7 days. ]

Central Contacts and Locations

Central contacts

Makayla Tosh, BSc.

9057075007mtosh@digestivehealth.ca

Locations

Digestive Health Clinic Research

Recruiting

Richmond Hill, Ontario, Canada, L9T2H4

Contacts

Makayla Tosh, BSc.

9057075007mtosh@digestivehealth.ca

More Information

Sponsor

Exzell Pharma Inc.

Last update posted

Oct 7, 2016

Last verified

Oct, 2016

Keywords

  • gluten
  • non-celiac
  • gluten sensitivity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Exzell Pharma Inc. on 2016-10-07.