A Phase 2 interventional study of Probiotic ES1 and Placebo in Non-Celiac Gluten Sensitivity, sponsored by Exzell Pharma Inc.. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-10-07.
Sponsored by Exzell Pharma Inc. · Phase 2, Interventional, and Treatment
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.
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).
1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.
This study's planned enrollment of 60 is close to the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →This is the only study on the registry with Exzell Pharma Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
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.
The efficacy of Probiotic ES1 using a 100-mm visual analog scale (VAS).
Time frame: Baseline to 7 days.
Adverse event assessment
The incidence and severity of adverse events.
Time frame: Baseline to 7 days.
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).
Time frame: Baseline to 7 days.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.