Upper Respiratory DiseaseNCT07431840
Immune Defense Protein Impact On Respiratory Immune Outcomes
A study testing Immune Defense Protein 50mg Dose and IDP 200mg Dose in people with Upper Respiratory Disease and Influenza, run by Quantec Ltd at 1 site in United States.
Trial summary
The primary goal of this study is to observe the impact of the IDP® Supplement on the duration and severity of upper respiratory symptoms in older individuals during the cold and flu season. Secondary aims include observing the product's effect on rescue medication use, quality of life, and overall tolerability. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Disease, Influenza, Viral Upper Respiratory Infection
- What is being tested?
- Immune Defense Protein 50mg Dose and IDP 200mg Dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60 years and older
- Individuals who experience upper respiratory symptoms (e.g. coughing, sneezing, congestion) at least 2-3 times during the cold/flu season.
- Able to read and understand English.
- Able to read, understand, and provide informed consent.
- Able to use a personal smartphone device and download Chloe by People Science.
- Able to receive shipment of the product at an address within the United States.
Who cannot join
- Any potential participants who:
- Do not have a personal smartphone, internet access, or unwilling to download Chloe.
- Already in an immunocompromised state, including:
- Infectious Causes
- HIV/AIDS
- Chronic hepatitis B or C (advanced stages)
Show all 37Show fewer
- Tuberculosis (especially disseminated or extrapulmonary TB) B. Cancer-Related
- Leukemia (e.g., AML, ALL, CLL)
- Lymphoma (e.g., Hodgkin's and Non-Hodgkin's)
- Multiple Myeloma
- Any metastatic cancer receiving chemotherapy
- Immunosuppressive Therapy:
- Participants on:
- Corticosteroids (e.g., ≥20 mg/day of prednisone for ≥2 weeks)
- Biologics (e.g., TNF inhibitors like infliximab, adalimumab)
- Calcineurin inhibitors (e.g., tacrolimus, cyclosporine)
- mTOR inhibitors (e.g., sirolimus)
- JAK inhibitors (e.g., tofacitinib)
- Chemotherapy or radiation therapy
- Anti-rejection meds post-organ transplant D. Transplant Patients
- Solid organ transplant (kidney, liver, heart, lung)
- Hematopoietic stem cell transplant (HSCT) E. Autoimmune or Inflammatory Diseases (especially when treated with immunosuppressants)
- Rheumatoid Arthritis
- Systemic Lupus Erythematosus (SLE)
- Psoriasis or Psoriatic Arthritis
- Inflammatory Bowel Disease (Crohn's disease, Ulcerative colitis)
- Multiple Sclerosis (especially on disease-modifying therapies)
- Other Concomitant Conditions and Therapies:
- Any investigational therapies or treatments within 30 days prior to enrollment.
- Known diagnosis of Asthma and/or COPD
- Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder
- Any underlying medical conditions or comorbidities that may confound the evaluation of the study outcomes
- Have a significant illness, disease or condition which, in the opinion of the principal investigator, may impact their ability to participate in the study or impact the study outcomes
- Use of cannabis-containing products daily
- Use of nicotine-containing products daily
- Known hypersensitivity or previous allergic reaction to milk products, Sorbitol and/or tabletting aids.
- Are unlikely for any reason to be able to comply with the trial or considered unsuited for participation in the study by the Principal Investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Azure Grant contact
United States1 site, 1 recruiting
- Recruiting
People Science, Inc.
Los Angeles, California, 90045
Noah Craft, M.D., Ph.D, 213-328-0919, noah@peoplescience.health
Azure Grant, azure@peoplescience.health
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Impact of IDP® Supplement on Respiratory Immune Health Outcomes During Cold and Flu Season in Older Individuals
The primary goal of this study is to observe the impact of the IDP® Supplement on the duration and severity of upper respiratory symptoms in older individuals during the cold and flu season. Secondary aims include observing the product's effect on rescue medication use, quality of life, and overall tolerability. This is conducted as a consumer-driven, decentralized observational clinical research study in adults aged 60 or older, using self-reported measures and questionnaires completed at home via the Chloe App.
Read the detailed description
The rationale for this study is to observe the impact of IDP® Supplement on upper respiratory tract symptoms, including duration and severity, in older individuals during the cold and flu season. Additionally, the study aims to observe the impact of the product on the type and frequency of use of rescue medication(s), the impact on individuals' activities and quality of life, and the overall tolerability of the study product. These endpoints will be assessed via activities and technologies that can successfully and effectively be completed in a home setting. A consumer-driven, decentralized observational clinical research study is therefore well-suited for examining the impact of this product in this population.
The investigators will examine the outcomes in adults aged 60 years or older who have chosen to try this product. The study will incorporate participant reported outcome questionnaires and surveys. There is no "doctor-patient" relationship as part of this research since the participant as a consumer is making the informed choice to take the product and take part in the observational process with self-reported measures and questionnaires completed at-home using the Chloe App. Findings from this study will contribute knowledge toward the tolerability, formulation, and design of future studies.
- Being tested
- Immune Defense Protein 50mg Dose, IDP 200mg Dose, Matching Placebo
- Keywords
- Cold, Flu, Viral Upper Respiratory Infection, URI, Influenza, Lungs, Upper Respiratory Tract, Upper Respiratory, Pneumonia
- Medical subject headings
- Respiration Disorders, Influenza, Human, Common Cold, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune Defense Protein 50mg DoseDietary supplement
IDP dose of 50mg
IDP 200mg DoseDietary supplement
IDP dose of 200mg
Matching PlaceboDietary supplement
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Study Product 50mg Dose | Experimental | 50mg of Study Product Receives: Dietary Supplement: Immune Defense Protein 50mg Dose |
| Group 2: Study Product 200mg Dose | Experimental | 200mg of Study Product Receives: Dietary Supplement: IDP 200mg Dose |
| Group 3: Matching Placebo | Placebo comparator | Participants will receive Matching Placebo Receives: Dietary Supplement: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact on Upper Respiratory Symptom Incidence, Duration and Severity
To evaluate the impact of IDP® Preventative Supplementation on incidence of upper respiratory symptoms, and the duration and severity of any symptoms that occur by measuring the change in incidence of upper respiratory symptoms (frequency, type, duration and severity) between study product and placebo groups. Baseline will be compared as well.
Measured: 17 weeks
Secondary outcomes (4)
Impact of IDP on Upper Respiratory Symptoms
To evaluate the impact of IDP® Supplement on Upper Respiratory symptoms by evaluating the change in Wisconsin Upper Respiratory Symptom Survey score ranging from a minimum of 0 (no symptoms) to a maximum of 140 (maximum severity), between product and placebo groups. Baseline will be compared as well.
Measured: 17 weeks
Impact on Rescue Medications
To evaluate the impact of IDP® Supplement on the frequency of use and type of rescue medications by measuring the change in the daily use and type of rescue medications used for Upper Respiratory symptoms between product and placebo groups. Baseline will be compared as well.
Measured: 17 weeks
Impact on Quality of Life
To evaluate the impact of IDP® on quality of life by measuring the change in the 36-Item Short Form Health Survey (SF-36) between product and placebo groups. The raw scores are transformed into a 0-100 scale, where 0 represents the lowest/worst health state and 100 the highest/best health state. Baseline will be compared as well.
Measured: 17 weeks
Safety and Tolerability Assessment
To evaluate the tolerability of IDP® Supplement by assessing the number, frequency, and severity of adverse events (AEs), serious adverse events (SAEs) and AE withdrawals reported over the study product and placebo use period.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start5 Dec 2025
- Primary completion19 May 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory DiseaseStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quantec Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431840
- Sponsor's protocol ID
- PS23
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Impact of IDP® Supplement on Respiratory Immune Health Outcomes During Cold and Flu Season in Older Individuals
- ClinicalTrials.gov ID
- NCT07431840
- Acronym / sponsor ID
- PS23
- Keywords
- Cold, Flu, Viral Upper Respiratory Infection, URI, Influenza, Lungs, Upper Respiratory Tract, Upper Respiratory
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Quantec LtdIndustry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 19 May 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 25 Feb 2026 (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 primary goal of this study is to observe the impact of the IDP® Supplement on the duration and severity of upper respiratory symptoms in older individuals during the cold and flu season. Secondary aims include observing the product's effect on rescue medication use, quality of life, and overall tolerability. This is conducted as a consumer-driven, decentralized observational clinical research study in adults aged 60 or older, using self-reported measures and questionnaires completed at home via the Chloe App.
Detailed description
The rationale for this study is to observe the impact of IDP® Supplement on upper respiratory tract symptoms, including duration and severity, in older individuals during the cold and flu season. Additionally, the study aims to observe the impact of the product on the type and frequency of use of rescue medication(s), the impact on individuals' activities and quality of life, and the overall tolerability of the study product. These endpoints will be assessed via activities and technologies that can successfully and effectively be completed in a home setting. A consumer-driven, decentralized observational clinical research study is therefore well-suited for examining the impact of this product in this population.
The investigators will examine the outcomes in adults aged 60 years or older who have chosen to try this product. The study will incorporate participant reported outcome questionnaires and surveys. There is no "doctor-patient" relationship as part of this research since the participant as a consumer is making the informed choice to take the product and take part in the observational process with self-reported measures and questionnaires completed at-home using the Chloe App. Findings from this study will contribute knowledge toward the tolerability, formulation, and design of future studies.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Study Product 50mg Dose | Experimental | Dietary Supplement: Immune Defense Protein 50mg Dose50mg of Study Product |
| Group 2: Study Product 200mg Dose | Experimental | Dietary Supplement: IDP 200mg Dose200mg of Study Product |
| Group 3: Matching Placebo | Placebo comparator | Dietary Supplement: Matching PlaceboParticipants will receive Matching Placebo |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 60 years and older
- Individuals who experience upper respiratory symptoms (e.g. coughing, sneezing, congestion) at least 2-3 times during the cold/flu season.
- Able to read and understand English.
- Able to read, understand, and provide informed consent.
- Able to use a personal smartphone device and download Chloe by People Science.
Key exclusion criteria (37 listed)
- Do not have a personal smartphone, internet access, or unwilling to download Chloe.
- Already in an immunocompromised state, including:
- Other Concomitant Conditions and Therapies:
- Use of cannabis-containing products daily
- Use of nicotine-containing products daily
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 |
|---|---|---|
| Immune Defense Protein 50mg DoseIDP dose of 50mg | Dietary supplement | Group 1: Study Product 50mg Dose |
| IDP 200mg DoseIDP dose of 200mg | Dietary supplement | Group 2: Study Product 200mg Dose |
| Matching PlaceboMatching Placebo | Dietary supplement | Group 3: Matching Placebo |
Primary outcome
Impact on Upper Respiratory Symptom Incidence, Duration and Severity
Time frame: 17 weeks
To evaluate the impact of IDP® Preventative Supplementation on incidence of upper respiratory symptoms, and the duration and severity of any symptoms that occur by measuring the change in incidence of upper respiratory symptoms (frequency, type, duration and severity) between study product and placebo groups. Baseline will be compared as well.
4 secondary outcomes
Impact of IDP on Upper Respiratory Symptoms
Time frame: 17 weeks
Impact on Rescue Medications
Time frame: 17 weeks
Impact on Quality of Life
Time frame: 17 weeks
Safety and Tolerability Assessment
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Azure Grant contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immune Defense Protein 50mg Dose and IDP 200mg Dose in people with Upper Respiratory Disease and Influenza, run by Quantec Ltd at 1 site in United States.
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 6 inclusion and 37 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: looking for participants now, as of the sponsor's last update on 12 Mar 2026. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noah Craft, M.D., Ph.D (213-328-0919, noah@peoplescience.health), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact on Upper Respiratory Symptom Incidence, Duration and Severity (time frame: 17 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2026.