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

NCT02810301 | Unknown Phase 2

• 1 other identifier: EX-ES01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

gluten; non-celiac; gluten sensitivity

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline to 7 days.

Secondary Outcomes (2)

• Adverse event assessment

  Baseline to 7 days.

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

  Baseline to 7 days.

Study Arms (2)

Treatment (Probiotic ES1)

EXPERIMENTAL

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.

Other: Probiotic ES1

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Probiotic ES1 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.

Also known as: Glutagest

Treatment (Probiotic ES1)

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Exzell Pharma Inc.: lead

Study Sites (1)

Digestive Health Clinic Research

Richmond Hill, Ontario, L9T2H4, Canada

RECRUITING

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Dr. Pardeep Nijhawan, MD

  Digestive Health Clinic / Exzell Pharma Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Makayla Tosh, BSc.

CONTACT

9057075007; mtosh@digestivehealth.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2016
• First Posted: June 22, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: October 7, 2016

Record last verified: 2016-10

Locations

CA (1)