The goal of this clinical trial is to test AllerPops' effectiveness in people who suffer from allergic rhinitis. The main question\[s\]it aims to answer are: 1. To assess the effectiveness of AllerPops on relieving nasal symptoms compared to the control group in volunteers with seasonal/year-long allergies during the first 7 days of the 21-day intervention period. 2. To evaluate the safety of AllerPops administration in volunteers with seasonal/year-long allergies during a 21-day intervention period. Up to 30 days between Screening (V1) and Baseline (V2), and a 21-day intervention period, with dosing occurring every other day for a minimum of 3 doses, and thereafter until the participant is satisfied with the relief of the nasal allergy symptoms. The suitable season for the trial will be determined based on the seasonal variation measures. Researchers will compare slow and fast consuming groups to see if the way of use impact the effectiveness.
Duration: Up to 30 days between Screening (V1) and Baseline (V2), and a 21-day intervention period, with dosing occurring every other day for a minimum of 3 doses, and thereafter until the participant is satisfied with the relief of the nasal allergy symptoms. The suitable season for the trial will be determined based on the seasonal variation measures. Primary Objectives: To assess the effectiveness of AllerPops on relieving nasal symptoms compared to the control group in volunteers with seasonal/year-long allergies during the first 7 days of the 21-day intervention period. Secondary Objective: 1. To evaluate the safety of AllerPops administration in volunteers with seasonal/year-long allergies during a 21-day intervention period. 2. To assess the duration of effectiveness of AllerPops in relieving nasal symptoms compared to the control group in volunteers with seasonal/year-long allergies during a 21-day intervention period (exploratory). 3. To evaluate the effect of the AllerPops administration on the oral microbial presentation/microbiota using Amplicon Metagenomics Sequencing test through saliva samples during a 21-day intervention period (exploratory). 4. To evaluate the effect of the AllerPops administration on the IgE (total) blood level during a 21-day intervention period (exploratory). Study Population: Seventy-two participants with seasonal/year-long nasal allergies. Duration: Up to 30 days between Screening (V1) and Baseline (V2), and a 21-day intervention period, with dosing occurring every other day for a minimum of 3 doses, and thereafter until the participant is satisfied with the relief of the nasal allergy symptoms. The suitable season for the trial will be determined based on the seasonal variation measures. Primary Objectives: To assess the effectiveness of AllerPops on relieving nasal symptoms compared to the control group in volunteers with seasonal/year-long allergies during the first 7 days of the 21-day intervention period. Secondary Objective: 1. To evaluate the safety of AllerPops administration in volunteers with seasonal/year-long allergies during a 21-day intervention period. 2. To assess the duration of effectiveness of AllerPops in relieving nasal symptoms compared to the control group in volunteers with seasonal/year-long allergies during a 21-day intervention period (exploratory). 3. To evaluate the effect of the AllerPops administration on the oral microbial presentation/microbiota using Amplicon Metagenomics Sequencing test through saliva samples during a 21-day intervention period (exploratory). 4. To evaluate the effect of the AllerPops administration on the IgE (total) blood level during a 21-day intervention period (exploratory). Study Population: Seventy-two participants with seasonal/year-long nasal allergies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
Take AllerPops once every other day, as instructed, for a minimum of 3 doses. After each dose, wait at least 30 minutes before eating your next meal. After the 3rd dose, you may continue every other day until you are satisfied with the symptom relief up to and including Day 13.
Dicentra
Toronto, Ontario, Canada
Allergy symptom changes measured by severity grade (0-3) in TNSS(Total Nasal Symptoms Score) Questionnaire.
To assess the effectiveness of AllerPops on changing nasal symptoms in volunteers with seasonal/year-long allergies during the first 7 days of the 21-day intervention period. Total Nasal Symptoms Score (TNSS) Questionnaire in grades of 0-3: a method developed to assess allergic rhinitis symptoms, based on the administration of a questionnaire. According to this method, allergic rhinitis symptoms are scored from 0 to 3 (4 grades of severity). This assessment will be conducted at the D1, D7, D14 and D21.
Time frame: 21-day
Nasal air flow changes measured by liter per minute in PNIF (Peak Nasal Inspiratory Flow) measurement.
To assess the effectiveness of AllerPops on altering nasal air flow in volunteers with seasonal/year-long allergies during the first 7 days of the 21-day intervention period. Peak Nasal Inspiratory Flow (PNIF) measured in liter per minute: Measures nasal flow for assessing nasal airway patency. This assessment will be conducted at the D1, D7, D14 and D21.
Time frame: 21-day
Number of participants with treatment-related adverse events as assessed by monitoring of vital signs, complete blood count, and a comprehensive safety panel.
To evaluate the safety of AllerPops administration in volunteers with seasonal/year-long allergies during a 21-day intervention period. a. Safety will be assessed by collecting vital signs (temperature, blood pressure, heart rate), the emergence of adverse events, and clinical chemistry (complete blood count, CBC \[Includes: White Blood Cell Count (WBC), Red Blood Cell Count (RBC), Hemoglobin (HB), Hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC), Platelet Count\] and a comprehensive safety panel: Aspartate aminotransferase (AST), Sodium, Potassium, Chloride, Serum creatinine, Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Bilirubin Total and Gamma Glutamyl Transpeptidase (GGT)), and PI assessment. This assessment will be conducted at the baseline D1, D7, D14 and D21.
Time frame: 21 days
Changes in participants' oral microbiomes using 16S amplicon metagenomic sequencing.
The exploratory study of the effect of AllerPops in oral microbial presentation/microbiota through Amplicon Metagenomics Sequencing test which is a rRNA gene (V3-V4 region) sequencing method in saliva. The evaluation will be measured at D1, D7 and D21.
Time frame: 21 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.