Efficacy of Probiotic ES1 for the Treatment of Non-Celiac Gluten Sensitivity
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|ClinicalTrials.gov Identifier: NCT02810301|
Recruitment Status : Recruiting
First Posted : June 22, 2016
Last Update Posted : October 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Non-Celiac Gluten Sensitivity||Other: Probiotic ES1 Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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.
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.
- 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).
- Adverse event assessment [ Time Frame: Baseline to 7 days. ]The incidence and severity of adverse events.
- 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).
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
|Contact: Makayla Tosh, BSc.||9057075007 ext firstname.lastname@example.org|
|Digestive Health Clinic Research||Recruiting|
|Richmond Hill, Ontario, Canada, L9T2H4|
|Contact: Makayla Tosh, BSc. 9057075007 ext 116 email@example.com|
|Principal Investigator:||Dr. Pardeep Nijhawan, MD||Digestive Health Clinic / Exzell Pharma Inc.|