Allergic RhinitisPhase 2NCT05956691
AllerPops Reduce Nasal Symptoms in Adult Volunteers With Allergic Rhinitis
A Phase 2 study testing AllerPops in people with Allergic Rhinitis, run by AllerPops Corp at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- AllerPops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- 5 Apr 2022to 21 Sep 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Participants will be clinically diagnosed with persistent or intermittent allergic rhinitis, according to the Allergic Rhinitis and Its Impact on Asthma (ARIA) classification. (The guidelines of Allergic Rhinitis and its Impact on Asthma (ARIA) group, classified it to intermittent (less than 4 days per week and for less than 4 weeks) and persistent (more than 4 days per week or lasting more than 4 weeks regardless of the number of days per week).
- 2. Male or female seasonal/year-long nasal allergy sufferers (as assessed by a questionnaire at screening) between the ages of 18 and 70.
- 3. Females who are not of childbearing potential (post-menopausal defined as those with amenorrhea for at least 2 years). Females of childbearing potential should be either sexually inactive (abstinent) for 60 days prior to the first dose of the study, throughout the study and for 30 days after completion of the study, or be using one of the following acceptable methods of birth control: i. Surgically sterile (bilateral tubal-ligation, hysterectomy, bilateral oophorectomy) for at least 90 days prior to the first dose of the study.
- IUD in place for at least 60 days prior to the first dose of the study, throughout the study and for 30 days after completion of the study.
- Barrier methods (condom, diaphragm) with spermicide for at least 60 days prior to the first dose of the study, throughout the study and for 30 days after study completion.
- Hormonal contraceptives for at least 90 days prior to the first dose of the study, throughout the study, and for 30 days after study completion.
Show all 16Show fewer
- Changes to the method of birth control while participating in the study will be judged by the PI for acceptability.
- 4. Written informed consent obtained and signed by participant. 5. BMI between 18.5 and 29.9 kg/m2, with a stable weight over the last 3 months. (A stable weight is defined as <5% of total body weight change in the last 3 months).
- 6. Agrees not to use any over the counter, prescription, health supplement or dietary supplement from at least 14 days prior to screening until the end of the study.
- 7. Agrees to maintain current dietary habits, level of physical activity, occupational and living environment for the trial duration.
- 8. Does not regularly consume more than 2 standard alcoholic beverages a day as assessed through verbal confirmation at screening, and agrees not to consume >2 standard alcoholic beverages per day for the trial duration.
- 9. Non-smoker within 12 months prior to dosing as assessed by verbal confirmation.
- 10. Stable medical conditions that do not require medication use routinely and do not affect or involve the immune systems as determined by medical history, physical examination, clinical chemistry performed at screening, and as assessed by the Principal Investigator.
- 11. Agrees not to use nasal steroid spray from at least 14 days prior to screening until the end of the study.
- 12. Agrees not to use neti-pot and oil-pulling for at least 7 days prior to screening until the end of the study.
- 13. . 14. Have access to a microwave.
Who cannot join
- Participants who are pregnant/lactating or planning to become pregnant during the course of the clinical trial.
- Participants who have any sings of active or recurrent upper airway infection (bacterial/viral).
- Participants who have a known sensitivity or allergy to any of the study products, or ingredients.
- Participation in another research study within 30 days prior to enrollment in this clinical trial.
- Participants who are not able to tolerate venipuncture and/or have poor venous access.
- Participants dependent on decongestants (nasal or oral) or receiving allergen-specific immunotherapy.
Show all 22Show fewer
- Participants who have been diagnosed with other clinical forms of rhinitis such as infectious rhinitis, rhinitis of pregnancy, food and alcohol-induced rhinitis, atrophic rhinitis, vasomotor rhinitis, rhinosinusitis and age-related rhinitis.
- Participants who have receive previous acupuncture treatment or alternative medicine for AR in the last three months or planned in the next two years.
- Participants who have received allergy desensitization therapy (current, during the past two years, or planned in the next two years).
- Participants who have had any major surgery within 1 year of enrollment into the clinical trial or have any anticipated major surgeries intended to occur during the clinical trial.
- Participants who have received a blood transfusion within 8 weeks of enrollment in the clinical trial.
- Participants who have donated blood or plasma to a blood bank or clinical study within 8 weeks of enrollment and during the study except venipuncture as part of clinical trial.
- Participant has known severe medical conditions, such as cardiovascular, liver or renal dysfunction, diabetes mellitus, cancers, cerebrovascular diseases, blood system diseases which in the opinion of the Principal Investigator, may preclude safe study participation, or interfere with study objectives.
- Participants who are immunocompromised or have been diagnosed HIV/AIDS, Hepatitis B, or untreated Hepatitis C.
- Participant has a history of alcohol or drug addiction treatment within the last 2 years prior to inclusion in the study, or any current addiction on alcohol or drugs.
- Participants with Grade II or III septum deviation and/or presence of nasal polyps or other conditions that lead to nasal obstruction.
- Participant has any other medical, social or other condition that, in the opinion of the Principal Investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
- Participants with allergic asthma and/or moderate to severe atopic dermatitis.
- History of anaphylactic reactions.
- Participants with any risk of developing dental cavity or on-going oral health issue, as assessed during their regular dentist visit in past 6 months.
- Participants who brush more than twice a day and/or mouthwash more than once a day and/or floss more than once a day.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Randomized, Double-blind, Controlled, Single-centre 21-day Study to Investigate the Efficacy of AllerPops to Reduce Nasal Symptoms in Adult Volunteers With Seasonal/Year-long Nasal Allergies
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:
- 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.
- To evaluate the safety of AllerPops administration in volunteers with seasonal/year-long allergies during a 21-day intervention period.
Read more
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.
Read the 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:
- To evaluate the safety of AllerPops administration in volunteers with seasonal/year-long allergies during a 21-day intervention period.
- 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).
- 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).
- 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:
- To evaluate the safety of AllerPops administration in volunteers with seasonal/year-long allergies during a 21-day intervention period.
- 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).
- 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).
- 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.
- Conditions
- Allergic Rhinitis
- Being tested
- AllerPops
- Keywords
- allergies, pollen, allergic rhinitis, common allergies, seasonal allergies, yearlong allergies, food allergies, autoimmune, prebiotics, probiotic, natural allergy relief
- Medical subject headings
- Rhinitis, Allergic, Hypersensitivity, Rhinitis, Allergic, Seasonal, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllerPopsDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Investigation | Experimental | Dosing Instructions
1. Brush teeth with water (no toothpaste).
2. Scrub tongue with warm, wet, washcloth from the back to the front until most of the white/yellow biofilm on the tongue is gone.
3. Gargle and swish hot (optimal 120°F) water for 10-20 seconds. Spit out and repeat gargling over the next 5 minutes. The tongue should be red and without any biofilm. If it is not, repeat Step 2, and gargle once more.
4. Self-administer one lozenge. Let the lozenge slowly melt in the mouth. Do not chew or swallow whole. This may take up to 60 minutes. Discard if it is not fully dissolved after 60 minutes.
5. Wash the washcloth to be ready before next use. Receives: Dietary Supplement: AllerPops |
| Control | Active comparator | Dosing Instructions
1. Microwave: heat the product in 5 second increments until soft. (Caution: more than 10 seconds of microwaving the product may cause it to burn).
2. Cut: cut the product into smaller pieces
3. Swallow: swallow without chewing the pieces with warm water while they are still warm. It can be swallowed over time or at once. Receives: Dietary Supplement: AllerPops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 21-day
Secondary outcomes (2)
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.
- 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.
Measured: 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.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start5 Apr 2022
- Primary completion5 Sep 2022
- Study completion21 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- AllerPops Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raj Gurinder, MD, Principal investigator, Independent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956691
- Sponsor's protocol ID
- 21-SAHSE-01
- Status last verified
- Jul 2023
- First submitted
- 16 Jun 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shunsheng Han C. Prebiotic supplements correct oral probiotic deficiency for lasting allergy relief. Am J Transl Res. 2024 Jan 15;16(1):136-146. doi: 10.62347/JWOU4205. eCollection 2024.
PubMed 38322553
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-blind, Controlled, Single-centre 21-day Study to Investigate the Efficacy of AllerPops to Reduce Nasal Symptoms in Adult Volunteers With Seasonal/Year-long Nasal Allergies
- ClinicalTrials.gov ID
- NCT05956691
- Acronym / sponsor ID
- 21-SAHSE-01
- Conditions
- Allergic Rhinitis
- Keywords
- allergies, pollen, allergic rhinitis, common allergies, seasonal allergies, yearlong allergies, food allergies, autoimmune
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- AllerPops CorpIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 5 Sep 2022 (actual)
- Study completion
- 21 Sep 2022 (actual)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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:
- To evaluate the safety of AllerPops administration in volunteers with seasonal/year-long allergies during a 21-day intervention period.
- 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).
- 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).
- 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:
- To evaluate the safety of AllerPops administration in volunteers with seasonal/year-long allergies during a 21-day intervention period.
- 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).
- 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).
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigation | Experimental | Dietary Supplement: AllerPopsDosing Instructions 1. Brush teeth with water (no toothpaste). 2. Scrub tongue with warm, wet, washcloth from the back to the front until most of the white/yellow biofilm on the tongue is gone. 3. Gargle and swish hot (optimal 120°F) water for 10-20 seconds. Spit out and repeat gargling over the next 5 minutes. The tongue should be red and without any biofilm. If it is not, repeat Step 2, and gargle once more. 4. Self-administer one lozenge. Let the lozenge slowly melt in the mouth. Do not chew or swallow whole. This may take up to 60 minutes. Discard if it is not fully dissolved after 60 minutes. 5. Wash the washcloth to be ready before next use. |
| Control | Active comparator | Dietary Supplement: AllerPopsDosing Instructions 1. Microwave: heat the product in 5 second increments until soft. (Caution: more than 10 seconds of microwaving the product may cause it to burn). 2. Cut: cut the product into smaller pieces 3. Swallow: swallow without chewing the pieces with warm water while they are still warm. It can be swallowed over time or at once. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 1. Participants will be clinically diagnosed with persistent or intermittent allergic rhinitis, according to the Allergic Rhinitis and Its Impact on Asthma (ARIA) classification. (The guidelines of Allergic Rhinitis and its Impact on Asthma (ARIA) group, classified it to intermittent (less than 4 days per week and for less than 4 weeks) and persistent (more than 4 days per week or lasting more than 4 weeks regardless of the number of days per week).
- 2. Male or female seasonal/year-long nasal allergy sufferers (as assessed by a questionnaire at screening) between the ages of 18 and 70.
- 3. Females who are not of childbearing potential (post-menopausal defined as those with amenorrhea for at least 2 years). Females of childbearing potential should be either sexually inactive (abstinent) for 60 days prior to the first dose of the study, throughout the study and for 30 days after completion of the study, or be using one of the following acceptable methods of birth control: i. Surgically sterile (bilateral tubal-ligation, hysterectomy, bilateral oophorectomy) for at least 90 days prior to the first dose of the study.
- IUD in place for at least 60 days prior to the first dose of the study, throughout the study and for 30 days after completion of the study.
- Barrier methods (condom, diaphragm) with spermicide for at least 60 days prior to the first dose of the study, throughout the study and for 30 days after study completion.
Key exclusion criteria (22 listed)
- Participants who are pregnant/lactating or planning to become pregnant during the course of the clinical trial.
- Participants who have any sings of active or recurrent upper airway infection (bacterial/viral).
- Participants who have a known sensitivity or allergy to any of the study products, or ingredients.
- Participation in another research study within 30 days prior to enrollment in this clinical trial.
- Participants who are not able to tolerate venipuncture and/or have poor venous access.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AllerPopsTake 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. | Dietary supplement | Control, Investigation |
Primary outcome
Allergy symptom changes measured by severity grade (0-3) in TNSS(Total Nasal Symptoms Score) Questionnaire.
Time frame: 21-day
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.
Nasal air flow changes measured by liter per minute in PNIF (Peak Nasal Inspiratory Flow) measurement.
Time frame: 21-day
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.
2 secondary outcomes
Number of participants with treatment-related adverse events as assessed by monitoring of vital signs, complete blood count, and a comprehensive safety panel.
Time frame: 21 days
Changes in participants' oral microbiomes using 16S amplicon metagenomic sequencing.
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Derived from this study: PubMed 38322553Shunsheng Han C. Prebiotic supplements correct oral probiotic deficiency for lasting allergy relief. Am J Transl Res. 2024 Jan 15;16(1):136-146. doi: 10.62347/JWOU4205. eCollection 2024.
- Individual participant dataSharing planned: No
Related trials for Allergic Rhinitis
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raj Gurinder, MD principal investigator
Independent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AllerPops in people with Allergic Rhinitis, run by AllerPops Corp at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Allergy symptom changes measured by severity grade (0-3) in TNSS(Total Nasal Symptoms Score) Questionnaire. (time frame: 21-day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05956691, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.