This is a 6 week study looking to assess the effectiveness of a beta-glucans supplement called M-Gard Particulate EW in adults who suffer from allergic rhinitis symptoms like a runny nose, sneezing, nasal congestion, itchy nose, and watery, red and itchy eyes.
M-Gard is a natural supplement made from baker’s yeast. It contains bioactive 1,3-1,6 beta-D-glucan, a type of complex polysaccharide, which has been shown to have immune modulating effects. Previous research has shown that beta-glucan supplementation may be of benefit to allergy sufferers to reduce symptom severity and improve quality of life.
We are looking to enrol 20 adults aged 18 – 65 years who have a known grass pollen allergy that causes seasonal allergic rhinitis.
In order to determine your suitability for this study, I'll go through some screening questions with you. If you wish to proceed, you will then be asked to sign an electronic Consent Form.
You will then need to attend your local Sullivan Nicolaides Pathology lab for a blood test to assess for a grass pollen allergy.
This will be arranged and paid for by RDC Clinical. Once all screening criteria (including a positive RAST result) have been met, you will be enrolled in the trial.
As this study is a cross over design, each participant will receive both the active and placebo product during the study.
Enrolled participants will take the first Study Product for 14 days, followed by a two week break with no product, and then take the alternative Study Product 2 for a further 14 days.
Neither you nor your Trial Coordinator will know the order in which you receive either the active or placebo product.
Whilst some of the study assessments can be completed at home, you will be required to attend our Fortitude Valley clinic on 4 occasions during the study period, at Baseline, Day 12, Day 29 and Day 41. These visits will include some measurements, questionnaires and a blood test.
Your Day 12 and Day 41 appointments will take approximately 3 hours each, and in this time you'll be required to undergo a Nasal Allergy Challenge.
The nasal allergen challenge (NAC) is a simple and safe technique for testing your response to allergens. Our trial doctor will perform it at the RDC clinic.
Upon arrival, you will have a cannula inserted into a vein and a small blood sample will be collected. After your initial blood sample, you'll be offered light refreshments.
A small amount of grass pollen allergen will then be administered via a metered-dose nasal spray. Typical allergy symptoms that you may experience include a runny nose, sneezing, blocked nose, red and watery eyes, and itching of the eyes and nose.
You'll then be asked to rate your symptoms by completing questionnaires and a peak flow inspiratory flow device will be used to measure the maximum amount of air that can be inhaled during one deep breath.
Most acute allergy symptoms triggered during a nasal allergen challenge test subside within approximately 15–30 minutes, however nasal congestion may persist for several hours. A delayed reaction can occur in some people.
Once the nasal allergen challenge has been conducted, additional blood samples will be collected, and then the cannula will be removed.
Rescue medication for symptom relief, such as nasal decongestants and antihistamines, will be provided at the end of the nasal allergen challenge if needed.
If you complete the study you'll be eligible for a reimbursement of up to $450 for your time and travel costs.
Do you have any questions?
Thank you for your time on the phone. We will email you a digital consent form to read and sign. Once we get that back from you, we'll send out a referral form.
Please take this to your local SNP for a RAST Blood test.
Please let us know by text or email once you've completed this test so we know to look out for your results.
Do you have any questions?
