AllerPops Reduce Nasal Symptoms in Adult Volunteers With Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): AllerPops
Intervention type(s): Dietary Supplement
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: allergies; pollen; allergic rhinitis; common allergies; seasonal allergies; yearlong allergies; food allergies; autoimmune; prebiotics; probiotic; natural allergy relief