ClinicalTrials.gg
RecruitingNCT07431840Updated Mar 12, 2026

Immune Defense Protein Impact On Respiratory Immune Outcomes

An interventional study of Immune Defense Protein 50mg Dose and IDP 200mg Dose in Upper Respiratory Disease, Influenza and Viral Upper Respiratory Infection, sponsored by Quantec Ltd. Recruiting at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-12.

Sponsored by Quantec Ltd · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started Dec 2025; still recruiting 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Upper Respiratory Disease
  • Influenza
  • Viral Upper Respiratory Infection

Keywords

  • Cold
  • Flu
  • Viral Upper Respiratory Infection
  • URI
  • Influenza
  • Lungs
  • Upper Respiratory Tract
  • Upper Respiratory
  • Pneumonia
03

In context

Respiration Disorders

359 studies on the registry are indexed under Respiration Disorders; 64 are open to participants now.

This study's planned enrollment of 300 is above the median of 69 across 216 interventional studies indexed under Respiration Disorders.

Browse Respiration Disorders studies →

Lead sponsor

This is the only study on the registry with Quantec Ltd as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 60 years and older
  2. Individuals who experience upper respiratory symptoms (e.g. coughing, sneezing, congestion) at least 2-3 times during the cold/flu season.
  3. Able to read and understand English.
  4. Able to read, understand, and provide .
  5. Able to use a personal smartphone device and download Chloe by People Science.
  6. Able to receive shipment of the product at an address within the United States.

Exclusion criteria

Exclusion Criteria:

Any potential participants who:

  1. Do not have a personal smartphone, internet access, or unwilling to download Chloe.
  2. Already in an state, including:

    A. Infectious Causes

    • /AIDS
    • Chronic or C (advanced stages)
    • 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 cancer receiving chemotherapy

    C. Immunosuppressive Therapy:

    Participants on:

    • (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 () E. 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)
  3. Other Concomitant Conditions and Therapies:

    1. Any therapies or treatments within 30 days prior to enrollment.
    2. Known diagnosis of Asthma and/or
    3. Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder
    4. Any underlying medical conditions or comorbidities that may confound the evaluation of the study outcomes
    5. 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
  4. Use of cannabis-containing products daily
  5. Use of nicotine-containing products daily
  6. Known or previous allergic reaction to milk products, Sorbitol and/or tabletting aids.
  7. 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.
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Group 1: Study Product 50mg Dose

    50mg of Study Product

    Dietary Supplement: Immune Defense Protein 50mg Dose

  • Experimental
    Group 2: Study Product 200mg Dose

    200mg of Study Product

    Dietary Supplement: IDP 200mg Dose

  • Placebo comparator
    Group 3: Matching Placebo

    Participants will receive Matching Placebo

    Dietary Supplement: Matching Placebo

Interventions

  • Dietary supplementImmune Defense Protein 50mg Dose

    IDP dose of 50mg

  • Dietary supplementIDP 200mg Dose

    IDP dose of 200mg

  • Dietary supplementMatching Placebo

    Matching Placebo

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 17 weeks

Secondary outcomes

  1. 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.

    Time frame: 17 weeks

  2. 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.

    Time frame: 17 weeks

  3. 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.

    Time frame: 17 weeks

  4. 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.

    Time frame: 16 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07431840
Lead sponsor
Quantec Ltd
Collaborators
People Science, Inc.
Responsible party
Sponsor
First posted
Feb 25, 2026
Start date
Dec 5, 2025
Primary completion
May 19, 2026 (estimated)
Completion
Jul 31, 2026 (estimated)
Last update
Mar 12, 2026

Study contacts

Noah Craft, M.D., Ph.D
Contact
noah@peoplescience.health
213-328-0919
Azure Grant
Contact
azure@peoplescience.health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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