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

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ClinicalTrials.gov Identifier: NCT02810301
Recruitment Status : Unknown
Verified October 2016 by Exzell Pharma Inc..
Recruitment status was:  Recruiting
First Posted : June 22, 2016
Last Update Posted : October 7, 2016
Sponsor:
Information provided by (Responsible Party):
Exzell Pharma Inc.

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.

Condition or disease Intervention/treatment Phase
Non-Celiac Gluten Sensitivity Other: Probiotic ES1 Other: Placebo Phase 2

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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : April 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
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.
Other: 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.
Other Name: Glutagest

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.
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.




Primary Outcome Measures :
  1. Change in mean overall symptoms (as assessed by a 100-mm visual analog scale) in active versus placebo. [ Time Frame: Baseline to 7 days. ]
    The efficacy of Probiotic ES1 using a 100-mm visual analog scale (VAS).


Secondary Outcome Measures :
  1. Adverse event assessment [ Time Frame: Baseline to 7 days. ]
    The incidence and severity of adverse events.

  2. Change in individual symptoms (as assessed by a 100-mm VAS) in active versus placebo. [ Time Frame: Baseline to 7 days. ]
    The efficacy of Probiotic ES1 using a 100-mm visual analog scale (VAS).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810301


Contacts
Contact: Makayla Tosh, BSc. 9057075007 ext 116 mtosh@digestivehealth.ca

Locations
Canada, Ontario
Digestive Health Clinic Research Recruiting
Richmond Hill, Ontario, Canada, L9T2H4
Contact: Makayla Tosh, BSc.    9057075007 ext 116    mtosh@digestivehealth.ca   
Sponsors and Collaborators
Exzell Pharma Inc.
Investigators
Principal Investigator: Dr. Pardeep Nijhawan, MD Digestive Health Clinic / Exzell Pharma Inc.

Responsible Party: Exzell Pharma Inc.
ClinicalTrials.gov Identifier: NCT02810301     History of Changes
Other Study ID Numbers: EX-ES01
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: October 7, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Exzell Pharma Inc.:
gluten
non-celiac
gluten sensitivity

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases
Sulfalene
Anti-Infective Agents
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents