Clinical trial NCT06907680: M-Gard Particulate EW Efficacy Study on Seasonal Allergic Rhinitis
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Allergic Rhinitis Due to Grass Pollens
Keywords: allergic rhinitis
Lead sponsor: RDC Clinical Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: Lallemand Bio-Ingredients
First posted: 2025-04-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, double-blind, placebo-controlled, cross-over trial
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Relief of symptoms of allergic rhinitis
timeFrame: Day 0 to Day 43
Secondary outcomes:
measure: Reflective Total Nasal Symptom Scores (rTNSS)
timeFrame: Day 0 to Day 43
measure: Reflective Total Ocular Symptom Scores (rTOSS)
timeFrame: Day 0 to Day 43
measure: Rhinitis Control Scoring System (RCSS)
timeFrame: Day 0 to Day 43
measure: Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).
timeFrame: Day 0 to Day 43
measure: Peak Nasal Inspiratory Flow (PNIF)
timeFrame: Day 0 to Day 43
measure: Onset of action of treatment
timeFrame: Day 12 and Day 41
measure: Pathology markers
timeFrame: Day 0 to Day 41
measure: Use of rescue /concomitant medications
timeFrame: Day 0 to Day 43
measure: Safety - Adverse events
timeFrame: Day 0 to Day 43
measure: Safety - Vital Signs (Blood Pressure)
timeFrame: Day 0 to Day 41
measure: Safety - Vital Signs (Heart Rate)
timeFrame: Day 0 to Day 41
measure: Safety - Vital Signs (O2 saturation)
timeFrame: Day 0 to Day 41
measure: Safety - Vital Signs (temperature)
timeFrame: Day 0 to Day 41
measure: Safety - Safety Markers (FBC)
timeFrame: Day 0 to Day 41
measure: Safety - Safety Markers (E/LFT)
timeFrame: Day 0 to Day 41
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: RDC Clinical
state: Queensland
Study officials:
affiliation: Lallemand Bio-Ingredients
name: Thomas Tompkins
role: STUDY_DIRECTOR
References: