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

Primary Purpose

Non-Celiac Gluten Sensitivity

Status

Unknown status

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Probiotic ES1

Placebo

About this trial

This is an interventional treatment trial for Non-Celiac Gluten Sensitivity focused on measuring gluten, non-celiac, gluten sensitivity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Digestive Health Clinic ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment (Probiotic ES1)

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Adverse event assessment

The incidence and severity of adverse events.

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).

Full Information

NCT ID

NCT02810301

First Posted

June 17, 2016

Last Updated

October 6, 2016

Sponsor

Exzell Pharma Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02810301

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Unknown status

Study Start Date

April 2016 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Exzell Pharma Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Celiac Gluten Sensitivity

Keywords

gluten, non-celiac, gluten sensitivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment (Probiotic ES1)

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Probiotic ES1

Other Intervention Name(s)

Glutagest

Intervention Description

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

Intervention Name(s)

Placebo

Intervention Description

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 Information:

Title

Change in mean overall symptoms (as assessed by a 100-mm visual analog scale) in active versus placebo.

Description

The efficacy of Probiotic ES1 using a 100-mm visual analog scale (VAS).

Time Frame

Baseline to 7 days.

Secondary Outcome Measure Information:

Title

Adverse event assessment

Description

The incidence and severity of adverse events.

Time Frame

Baseline to 7 days.

Title

Change in individual symptoms (as assessed by a 100-mm VAS) in active versus placebo.

Description

The efficacy of Probiotic ES1 using a 100-mm visual analog scale (VAS).

Time Frame

Baseline to 7 days.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Makayla Tosh, BSc.

Phone

9057075007

Ext

116

mtosh@digestivehealth.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr. Pardeep Nijhawan, MD

Organizational Affiliation

Digestive Health Clinic / Exzell Pharma Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Digestive Health Clinic Research

City

Richmond Hill

State/Province

Ontario

ZIP/Postal Code

L9T2H4

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Makayla Tosh, BSc.

Phone

9057075007

Ext

116

mtosh@digestivehealth.ca

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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