M-Gard Particulate EW Efficacy Study on Seasonal Allergic Rhinitis

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis Due to Grass Pollens
• Intervention / Treatment: Dietary supplement: M-Gard; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4006
      • RDC Clinical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: M-Gard; One capsule containing 250mg of M-Gard Particulate EW is taken twice daily for 14 days.	Dietary supplement: M-Gard; One capsule containing 250mg of M-Gard Particulate EW is taken twice daily for 14 days.; Other Names: M-Gard Particulate EW
Placebo Comparator: Placebo; One capsule containing 250mg of MCC (Microcrystalline Cellulose) is taken twice daily for 14 days.	Other: Placebo; One capsule containing 250mg of MCC (Microcrystalline Cellulose) is taken twice daily for 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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
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
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

Collaborators and Investigators

• Sponsor: RDC Clinical Pty Ltd
• Collaborators: Lallemand Bio-Ingredients
• Investigators: Study Director: Thomas Tompkins, Lallemand Bio-Ingredients

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2025
• Primary Completion (Actual): January 29, 2026
• Study Completion (Actual): January 29, 2026

Study Registration Dates

• First Submitted: March 27, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: allergic rhinitis
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: BETALL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No