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

NCT ID: NCT02810301

Last Updated: 2016-10-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2018-01-31

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).

Conditions

Non-Celiac Gluten Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Probiotic ES1

Intervention Type: OTHER

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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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.

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Other Intervention Names

Glutagest

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Exzell Pharma Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Pardeep Nijhawan, MD

Role: PRINCIPAL_INVESTIGATOR

Digestive Health Clinic / Exzell Pharma Inc.

Locations

Digestive Health Clinic Research

Richmond Hill, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Makayla Tosh, BSc.

Role: CONTACT

mtosh@digestivehealth.ca

9057075007 ext. 116

Facility Contacts

Makayla Tosh, BSc.

Role: primary

mtosh@digestivehealth.ca

9057075007 ext. 116

Other Identifiers

EX-ES01

Identifier Type: -

Identifier Source: org_study_id