NEW STUDY ANNOUNCEMENT

Grass Allergy Study

Are you aged between 18-65 and suffer from hay fever caused by an allergy to grass?

IMPORTANT: as part of this study the investigators will attempt to trigger an allergic response to grass allergens in a clinical environment. Therefore, we are seeking people who are NOT experiencing allergy symptoms at the time of enrolment.

Thank you for your interest in our study which is investigating the efficacy of a supplement containing beta 1,3-1,6 glucans in reducing the symptoms of seasonal allergic rhinitis (hay fever) due to grass pollen allergy.

Please note: This page is a summary of the study outline and participant requirements. A full Participant Information Sheet with detailed information will be provided to you before you are asked to give your consent to participate.

Why is this study being conducted?

Grass pollen allergy is one of the most common causes of hay fever (seasonal allergic rhinitis), and symptoms typically occur during the Spring and Summer months. Allergic rhinitis is a common condition and is estimated to affect around 23% of the Australian population. Characteristic symptoms include runny nose, sneezing, nasal congestion, itchiness of the nose and throat, as well as tearing and redness of the eyes. It can negatively affect overall well-being and quality of life.

Current treatment options for hay fever symptoms include medications such as antihistamines and decongestants. Many people turn to complementary medicines and supplements to manage their allergies; therefore, it is important to investigate the effectiveness and safety of alternative treatment options.

How long is the study, and when does it start?

Your involvement in this study will be approximately 7 weeks, 4 of which you will be required to take the study product. Some of the study assessments can be completed from home, however you will be asked to visit our clinic on four occasions. The questionnaires will take approximately 10 minutes to complete on each occasion. It is estimated that the study will take about 10 hours of your time in total. There are no overnight visits required.

To make the timings of these visits as convenient as possible for you, we are recruiting on a rolling basis. This means that your individual start date is flexible.

Please see below for more information. You can also register your interest using the form on this page.

About the product you’ll help investigate…

The investigational product is a supplement containing beta 1,3-1,6 glucans, which is a beta-D-glucan derived from baker’s yeast. Studies have shown that beta 1,3-1,6 glucans supplements have immune modulating properties and may be of benefit to allergy sufferers to reduce symptoms.

The product will be supplied in capsule form, and participants will be asked to take one capsule twice daily before food.

This study is placebo-controlled, and it is also a cross over design. This means that each person in the study will take the active product for a period of 2 weeks, and also take the placebo product for a period of 2 weeks. Neither you nor the investigators will know which order the products will be allocated to you. Upon enrolment, you will be randomly allocated to one of 2 groups.

  • Group 1 participants will receive the active product first, then the placebo.
  • Group 2 participants will receive the placebo first, then the active.

The product order is allocated randomly on a chance basis, and you will not know which product group you have been allocated to. This is to ensure that no unintentional bias can impact the results.

Placebos are designed to look like the real product being studied except they do not contain the active ingredient. Using a placebo helps us to be confident that any effects we measure in the active group really are due to the active ingredient and not due to the body’s own reaction to a perceived treatment.

Please note: This page is a summary of the study outline and participant requirements. A full Participant Information Sheet with detailed information will be provided to you before you are asked to give your consent to participate.

What is required of participants?

Your involvement in the study will be for approximately 7 weeks. Some of the study requirements can be completed online at home; however, you will be required to attend our clinic (in Fortitude Valley, Brisbane) 4 times during the study.

There will be TWO nasal challenge tests which involve exposure to grass allergen which will be administered in the clinic by our trial doctor.

The study design is:

  • Clinic Visit: Complete baseline questionnaires and blood test
  • At home: Take Product 1 twice daily for 12 days
  • Clinic Visit: Complete questionnaires, blood test and Nasal allergen challenge test
  • At home: Take Product 1 twice daily for a further 2 days (and complete follow up questionnaires)

2 week washout period, not taking any study product

  • Clinic Visit: Complete baseline questionnaires and blood test
  • At home: Take Product 2 twice daily for 12 days
  • Clinic Visit: Complete questionnaires, blood test and Nasal allergen challenge test
  • At home: Take Product 2 twice daily for a further 2 days (and complete follow up questionnaires)

The information we collect during the study will enable the investigators to assess the product’s efficacy in improving the symptoms associated with grass allergy.

    COMPENSATION

    Upon completion of the study requirements, you will be eligible to be paid $450 for your time and travel expenses. The payment will be made by gift voucher or via direct deposit to your nominated bank account (your choice) once all study requirements have been met.

    Pro rata payments are also available in the case of early withdrawal.

    If you are interested in participating, we’d love to hear from you. Please register your interest by answering the questionnaire and completing the form on this page…we’ll then get in touch to screen you for eligibility.

    Study location…

    Our clinic is centrally located on Level 3, 252 St Pauls Terrace, Fortitude Valley.

    We offer free undercover parking directly next door under the Kennigo Hotel, 22 Kennigo Street, Fortitude Valley.

    Getting to Us

    Private Transport: free undercover parking available at Kennigo Hotel Car Park as well as metered street parking (availability for street parking is day/time dependent). Please enter 22 Kennigo Street Fortitude Valley into your GPS.
    Train: Fortitude Valley Train Station (350m away)
    Bus: multiple bus stops within close proximity

    Please register your interest by answering the questionnaire and completing the form on this page… we’ll then get in touch to screen you for suitability.

    Please note: This page is a summary of the study outline and participant requirements. A full Participant Information Sheet with more detailed information will be provided to you before you are asked to give your consent to participate.

    Check if you can register to take part…

    For this study we are looking for people suffer from hay fever, specifically to grasses.

    • Adults 18-65 years of age
    • Allergic to grass pollen (confirmed or suspected) (As part of the screening process, RDC will arrange for all potential participants to have a blood test to confirm grass allergy)
    • Usually experience symptoms in ‘allergy season’ but not experiencing symptoms at the time of enrolment
    • Generally healthy
    • Able to provide informed consent
    • Able to commit to completing the study requirements, including attending our Brisbane clinic on 4 occasions.

    IMPORTANT: as part of this study the investigators will attempt to trigger an allergic response to grass allergens in a clinical environment. Therefore, we are seeking people who are NOT experiencing allergy symptoms at the time of enrolment.

    Ethics approval and privacy

    This RDC Clinical study has been approved by the Bellberry Human Research Ethics Committee under Approval Number:  2025-02-222. The study is also registered on the clinicaltrials.gov under Registration Number: NCT06907680.

    Trained trial coordinators will supervise your progress throughout the study. Your results will be made available to you at the conclusion of the study. Any of your personal information collected during the study will be kept in the strictest confidence.