M-Gard Particulate EW Efficacy Study on Seasonal Allergic Rhinitis

NCT06907680 | Completed Phase 2

• 1 other identifier: BETALL
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis Due to Grass Pollens

Keywords

allergic rhinitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Reflective Total Nasal Symptom Scores (rTNSS)

  Day 0 to Day 43

• Reflective Total Ocular Symptom Scores (rTOSS)

  Day 0 to Day 43

• Rhinitis Control Scoring System (RCSS)

  Day 0 to Day 43

• Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).

  Day 0 to Day 43

• Peak Nasal Inspiratory Flow (PNIF)

  Day 0 to Day 43

Study Arms (2)

M-Gard

EXPERIMENTAL

One capsule containing 250mg of M-Gard Particulate EW is taken twice daily for 14 days.

Dietary Supplement: M-Gard

Placebo

PLACEBO COMPARATOR

One capsule containing 250mg of MCC (Microcrystalline Cellulose) is taken twice daily for 14 days.

Other: Placebo

Interventions

M-Gard DIETARY_SUPPLEMENT

One capsule containing 250mg of M-Gard Particulate EW is taken twice daily for 14 days.

Also known as: M-Gard Particulate EW

M-Gard

Placebo OTHER

One capsule containing 250mg of MCC (Microcrystalline Cellulose) is taken twice daily for 14 days.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• RDC Clinical Pty Ltd: lead
• Lallemand Bio-Ingredients: collaborator

Study Sites (1)

RDC Clinical

Brisbane, Queensland, 4006, Australia

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Thomas Tompkins

  Lallemand Bio-Ingredients

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, cross-over trial

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 2, 2025
• Study Start: June 27, 2025
• Primary Completion: January 29, 2026
• Study Completion: January 29, 2026
• Last Updated: March 6, 2026

Record last verified: 2025-03

Locations

AU (1)