Non-Celiac Gluten SensitivityPhase 2NCT02810301
Efficacy of Probiotic ES1 for the Treatment of Non-Celiac Gluten Sensitivity
A Phase 2 study testing Probiotic ES1 in people with Non-Celiac Gluten Sensitivity, run by Exzell Pharma Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-Celiac Gluten Sensitivity
- What is being tested?
- Probiotic ES1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2016to Jan 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Digestive Health Clinic Research
Richmond Hill, Ontario, L9T2H4
Makayla Tosh, BSc., 9057075007 ext. 116, mtosh@digestivehealth.ca
About this study
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 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.
Read the 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).
- Conditions
- Non-Celiac Gluten Sensitivity
- Being tested
- Probiotic ES1, Placebo
- Keywords
- gluten, non-celiac, gluten sensitivity
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic ES1Other
Also called Glutagest
- 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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to 7 days.
Secondary outcomes (2)
Adverse event assessment
The incidence and severity of adverse events.
Measured: 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).
Measured: Baseline to 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Celiac Gluten SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Exzell Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Pardeep Nijhawan, MD, Principal investigator, Digestive Health Clinic / Exzell Pharma Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810301
- Sponsor's protocol ID
- EX-ES01
- Status last verified
- Oct 2016
- First submitted
- 17 Jun 2016
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02810301
- Acronym / sponsor ID
- EX-ES01
- Conditions
- Non-Celiac Gluten Sensitivity
- Keywords
- gluten, non-celiac, gluten sensitivity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Exzell Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment (Probiotic ES1) | Experimental | Other: Probiotic ES1Capsules containing 1 billion CFU of B. longum ES1 per capsule. One capsule taken before and after consuming 2 slices of bread for 7 days. |
| Placebo | Placebo comparator | Other: PlaceboCapsules not containing the active ingredient B. longum ES1. One capsule taken before and after consuming 2 slices of bread for 7 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic ES1Also: GlutagestB. 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 | Treatment (Probiotic ES1) |
| PlaceboThe 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. | Other | Placebo |
Primary outcome
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).
2 secondary outcomes
Adverse event assessment
Time frame: Baseline to 7 days.
Change in individual symptoms (as assessed by a 100-mm VAS) in active versus placebo.
Time frame: Baseline to 7 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Pardeep Nijhawan, MD principal investigator
Digestive Health Clinic / Exzell Pharma Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic ES1 in people with Non-Celiac Gluten Sensitivity, run by Exzell Pharma Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Makayla Tosh, BSc. (9057075007 ext. 116, mtosh@digestivehealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean overall symptoms (as assessed by a 100-mm visual analog scale) in active versus placebo. (time frame: Baseline to 7 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2016.