Allergic Rhinitis Due to Grass PollensPhase 2NCT06907680
M-Gard Particulate EW Efficacy Study on Seasonal Allergic Rhinitis
A Phase 2 study testing M-Gard in people with Allergic Rhinitis Due to Grass Pollens, run by RDC Clinical Pty Ltd at 1 site in Australia.
Trial summary
The goal of this clinical trial is to assess the efficacy and safety of M-Gard supplementation for alleviating the symptoms of allergic rhinitis. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis Due to Grass Pollens
- What is being tested?
- M-Gard
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- 27 Jun 2025to 29 Jan 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years.
- Generally healthy
- Individuals with a history of recurrent seasonal allergic rhinitis
- Positive RAST test for grass allergy
- BMI 18-35kg/m2
- Able to provide informed consent
- Agree not to change current diet and/or exercise routine during entire enrolment period
- Agree to not participate in another clinical trial during the study period
Who cannot join
- Serious illness e.g., liver disease, kidney disease, heart disease, mood disorders, neurological disorders such as multiple sclerosis.
- Unstable illness e.g., diabetes and thyroid gland dysfunction.
- Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years.
- Individuals with symptomatic perennial allergic rhinitis, non-allergic rhinitis, chronic respiratory conditions (e.g., asthma, chronic obstructive pulmonary disease).
- Participants with cognitive damage.
- Acute illness experienced in the past 1 month.
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- Active smokers and/or nicotine or drug abuse.
- Allergic to any of the ingredients in the active or placebo formula.
- Chronic past and/or current alcohol use (>21 alcoholic drinks per week)
- Attempting to conceive, pregnant or lactating women
- Use of medications that would affect the immune and/or the inflammatory response e.g. immunotherapy, antihistamines (daily use), corticosteroids, mast cell stabilizers, leukotriene modifiers, and decongestants.
- Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy including low dose aspirin; tricyclic antidepressants; Clonidine and other central acting alpha-2-agonists.
- Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month.
- Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Placebo-controlled Crossover Trial Assessing the Efficacy and Safety of M-Gard Particulate EW in the Treatment of Seasonal Allergic Rhinitis
The goal of this clinical trial is to assess the efficacy and safety of M-Gard supplementation for alleviating the symptoms of allergic rhinitis.
- Conditions
- Allergic Rhinitis Due to Grass Pollens
- Being tested
- M-Gard, Placebo
- Keywords
- allergic rhinitis
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-GardDietary supplement
Also called M-Gard Particulate EW
One capsule containing 250mg of M-Gard Particulate EW is taken twice daily for 14 days.
PlaceboOther
One capsule containing 250mg of MCC (Microcrystalline Cellulose) is taken twice daily for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| M-Gard | Experimental | One capsule containing 250mg of M-Gard Particulate EW is taken twice daily for 14 days. Receives: Dietary Supplement: M-Gard |
| Placebo | Placebo comparator | One capsule containing 250mg of MCC (Microcrystalline Cellulose) is taken twice daily for 14 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief of symptoms of allergic rhinitis
Relief of symptoms of allergic rhinitis, as measured by:
Total and individual allergic rhinitis symptom severity as measured by a visual analogue scale (VAS) of nasal congestion, sneezing, itchy nose, runny nose and watery eyes. These symptoms will be rated on a scale of 0 to 10 where 0 is "not troublesome at all" and 10 is "very troublesome".
Measured: Day 0 to Day 43
Secondary outcomes (15)
Reflective Total Nasal Symptom Scores (rTNSS)
Change from baseline to the end of the study period in Reflective Total Nasal Symptom Scores (rTNSS). Self-reported questionnaire rating the severity of four nasal symptoms (runny nose, nasal congestion, itchy nose, and sneezing) on a four-point scale (0-3), where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The rTNSS is the sum of the scores for each of the nasal symptoms (from 0 to 12)
Measured: Day 0 to Day 43
Reflective Total Ocular Symptom Scores (rTOSS)
Change from baseline to the end of the study period in Reflective Total Ocular Symptom Scores (rTOSS). Self-reported questionnaire that is calculated as the sum of the patients' scoring of the severity of three ocular symptoms (itching/burning, tearing/watering, and redness) on a scale of 0-3 where 0 = absent, 1 = mild, 2 = moderate, and 3 = severe).
Measured: Day 0 to Day 43
Rhinitis Control Scoring System (RCSS)
Change from baseline to the end of the study period in Rhinitis Control Scoring System (RCSS). Subject-completed tool including 5 items (sneezing, rhinorrhoea, nasal obstruction, nasal pruritus, and conjunctivitis). Each symptom is rated on a 5-point scale depending on its intensity (none-10%, mild-8%, moderate-6%, severe-4%, very severe-2%) and its frequency (never-10%, rarely-8%, occasionally-6%, frequently-4%, very frequently-2%), which are assessed separately. The sum of the intensity score and the frequency score gives the global score
Measured: Day 0 to Day 43
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).
Change from baseline to the end of the study period in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). Self-reported questionnaire used measure the functional impairments that are most troublesome to patients because of their rhinoconjunctivitis. It consists of 28 questions in 7 domains (activity limitation, sleep problems, nose symptoms, eye symptoms, non-nose/eye symptoms, practical problems and emotional function). These are rated on a 7-point scale (0 = not impaired at all - 6 = severely impaired).
Measured: Day 0 to Day 43
Peak Nasal Inspiratory Flow (PNIF)
Change from baseline to the end of the study period in Peak Nasal Inspiratory Flow (PNIF). Peak nasal inspiratory flow (PNIF) is a measure of nasal patency and measures the maximum airflow a patient is able to produce during forced nasal inspiration. PNIF (in L/min) will be measured with a peak inspiratory flow meter. The highest of three successive measurement values will be recorded
Measured: Day 0 to Day 43
Onset of action of treatment
Change from baseline to the end of the study period in onset of action of treatment, this will be measured during the nasal allergen challenge. Peak nasal inspiratory flow (PNIF) will be measured to assess for nasal patency and allergy symptoms will be rated via the VAS, rTNSS, rTOSS, RCSS and RQLQ.
The time from the onset of symptoms to their resolution will be measured.
Measured: Day 12 and Day 41
Pathology markers
Change from baseline to the end of the study period in Pathology markers: cytokines, histamine, tryptase, allergen specific IgE.
Measured: Day 0 to Day 41
Use of rescue /concomitant medications
Change from baseline to the end of the study period in use of rescue /concomitant medications.
Measured: Day 0 to Day 43
Safety - Adverse events
Change from baseline to the end of the study period in Safety via Adverse Event reporting and incident rate ratio between placebo and treatment groups.
Measured: Day 0 to Day 43
Safety - Vital Signs (Blood Pressure)
Change from baseline to the end of the study period in Safety via Vital Signs (blood pressure).
Measured: Day 0 to Day 41
Safety - Vital Signs (Heart Rate)
Change from baseline to the end of the study period in Safety via Vital Signs heart rate.
Measured: Day 0 to Day 41
Safety - Vital Signs (O2 saturation)
Change from baseline to the end of the study period in Safety via Vital Signs (O2 saturation).
Measured: Day 0 to Day 41
Safety - Vital Signs (temperature)
Change from baseline to the end of the study period in Safety via Vital Signs (temperature).
Measured: Day 0 to Day 41
Safety - Safety Markers (FBC)
Change from baseline to the end of the study period in Safety via Safety Markers (Full Blood Count).
Measured: Day 0 to Day 41
Safety - Safety Markers (E/LFT)
Change from baseline to the end of the study period in Safety via Safety Markers (E/LFT).
Measured: Day 0 to Day 41
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start27 Jun 2025
- Primary completion29 Jan 2026
- Study completion29 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic Rhinitis Due to Grass PollensStudies of the same condition, open and under way.
- More trials run by RDC Clinical Pty LtdThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- Randomized, double-blind, placebo-controlled, cross-over trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- RDC Clinical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lallemand Bio-Ingredients
- Responsible party
- Sponsor
- Investigators
- Thomas Tompkins, Study director, Lallemand Bio-Ingredients
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907680
- Sponsor's protocol ID
- BETALL
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Briskey D, Pellow J, Beatson G, Tremblay A, Rao A, Tompkins TA. Efficacy and safety of a particulate yeast beta-glucan preparation in the treatment of seasonal allergic rhinitis (BETALL): a randomised placebo-controlled crossover trial protocol. Trials. 2026 Apr 17;27(1):398. doi: 10.1186/s13063-026-09702-7.
PubMed 41998746
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-controlled Crossover Trial Assessing the Efficacy and Safety of M-Gard Particulate EW in the Treatment of Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT06907680
- Acronym / sponsor ID
- BETALL
- Conditions
- Allergic Rhinitis Due to Grass Pollens
- Keywords
- allergic rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- RDC Clinical Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Lallemand Bio-Ingredients
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 29 Jan 2026 (actual)
- Study completion
- 29 Jan 2026 (actual)
- First posted
- 2 Apr 2025 (actual)
- 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.
The goal of this clinical trial is to assess the efficacy and safety of M-Gard supplementation for alleviating the symptoms of allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, cross-over trial
| Arm | Type | Receives |
|---|---|---|
| M-Gard | Experimental | Dietary Supplement: M-GardOne capsule containing 250mg of M-Gard Particulate EW is taken twice daily for 14 days. |
| Placebo | Placebo comparator | Other: PlaceboOne capsule containing 250mg of MCC (Microcrystalline Cellulose) is taken twice daily for 14 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 18-65 years.
- Generally healthy
- Individuals with a history of recurrent seasonal allergic rhinitis
- Positive RAST test for grass allergy
- BMI 18-35kg/m2
Key exclusion criteria (14 listed)
- Serious illness e.g., liver disease, kidney disease, heart disease, mood disorders, neurological disorders such as multiple sclerosis.
- Unstable illness e.g., diabetes and thyroid gland dysfunction.
- Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years.
- Individuals with symptomatic perennial allergic rhinitis, non-allergic rhinitis, chronic respiratory conditions (e.g., asthma, chronic obstructive pulmonary disease).
- Participants with cognitive damage.
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 |
|---|---|---|
| M-GardAlso: M-Gard Particulate EWOne capsule containing 250mg of M-Gard Particulate EW is taken twice daily for 14 days. | Dietary supplement | M-Gard |
| PlaceboOne capsule containing 250mg of MCC (Microcrystalline Cellulose) is taken twice daily for 14 days. | Other | Placebo |
Primary outcome
Relief of symptoms of allergic rhinitis
Time frame: Day 0 to Day 43
Relief of symptoms of allergic rhinitis, as measured by: Total and individual allergic rhinitis symptom severity as measured by a visual analogue scale (VAS) of nasal congestion, sneezing, itchy nose, runny nose and watery eyes. These symptoms will be rated on a scale of 0 to 10 where 0 is "not troublesome at all" and 10 is "very troublesome".
15 secondary outcomes
Reflective Total Nasal Symptom Scores (rTNSS)
Time frame: Day 0 to Day 43
Reflective Total Ocular Symptom Scores (rTOSS)
Time frame: Day 0 to Day 43
Rhinitis Control Scoring System (RCSS)
Time frame: Day 0 to Day 43
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).
Time frame: Day 0 to Day 43
Peak Nasal Inspiratory Flow (PNIF)
Time frame: Day 0 to Day 43
Onset of action of treatment
Time frame: Day 12 and Day 41
Pathology markers
Time frame: Day 0 to Day 41
Use of rescue /concomitant medications
Time frame: Day 0 to Day 43
Safety - Adverse events
Time frame: Day 0 to Day 43
Safety - Vital Signs (Blood Pressure)
Time frame: Day 0 to Day 41
Safety - Vital Signs (Heart Rate)
Time frame: Day 0 to Day 41
Safety - Vital Signs (O2 saturation)
Time frame: Day 0 to Day 41
Safety - Vital Signs (temperature)
Time frame: Day 0 to Day 41
Safety - Safety Markers (FBC)
Time frame: Day 0 to Day 41
Safety - Safety Markers (E/LFT)
Time frame: Day 0 to Day 41
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Derived from this study: PubMed 41998746Briskey D, Pellow J, Beatson G, Tremblay A, Rao A, Tompkins TA. Efficacy and safety of a particulate yeast beta-glucan preparation in the treatment of seasonal allergic rhinitis (BETALL): a randomised placebo-controlled crossover trial protocol. Trials. 2026 Apr 17;27(1):398. doi: 10.1186/s13063-026-09702-7.
- 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.
Thomas Tompkins study director
Lallemand Bio-Ingredients
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 M-Gard in people with Allergic Rhinitis Due to Grass Pollens, run by RDC Clinical Pty Ltd at 1 site in Australia.
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 14 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: finished, as of the sponsor's last update on 6 Mar 2026. 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 Australia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relief of symptoms of allergic rhinitis (time frame: Day 0 to Day 43). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06907680, which also lists 1 linked publication.
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 6 Mar 2026.