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| Name | Class |
|---|---|
| Lallemand Bio-Ingredients | OTHER |
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The goal of this clinical trial is to assess the efficacy and safety of M-Gard supplementation for alleviating the symptoms of allergic rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M-Gard | Experimental | One capsule containing 250mg of M-Gard Particulate EW is taken twice daily for 14 days. |
|
| Placebo | Placebo Comparator | One capsule containing 250mg of MCC (Microcrystalline Cellulose) is taken twice daily for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M-Gard | Dietary Supplement | One capsule containing 250mg of M-Gard Particulate EW is taken twice daily for 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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". | Day 0 to Day 43 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Tompkins | Lallemand Bio-Ingredients | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RDC Clinical | Brisbane | Queensland | 4006 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41998746 | Derived | 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. |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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Randomized, double-blind, placebo-controlled, cross-over trial
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| Placebo | Other | One capsule containing 250mg of MCC (Microcrystalline Cellulose) is taken twice daily for 14 days. |
|
| 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). | 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 | 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). | 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 | 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. | 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. | 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. | 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. | 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). | 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. | 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). | 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). | 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). | 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). | Day 0 to Day 41 |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |