ClinicalTrials.gg
RecruitingNCT07787130CELFIUpdated Oct 13, 2026

Effect of Immune X on Common Cold Incidence in Healthy Adults

An interventional study of Immune X and Placebo in Common Cold and Upper Respiratory Tract Infection (URTI), sponsored by Givaudan France Naturals. Recruiting at 1 site in France. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Givaudan France Naturals · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Oct 2026; still recruiting 1 month later.
Updated Oct 7, 2026Now RecruitingFirst site in France+4 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The goal of this clinical trial is to learn if Immune X can help prevent common cold events in healthy adults who have a history of upper respiratory tract infections. The main questions it aims to answer are:

  • Does Immune X reduce the proportion of participants who experience at least one clinically confirmed common cold event during the study period?
  • Does Immune X affect the number, duration, and severity of common cold events?

Researchers will compare Immune X to a placebo (a look-alike capsule containing inactive ingredients) to see if Immune X helps prevent common cold events.

Participants will:

  • Take Immune X or placebo daily for 16 weeks during the winter season.
  • Attend study visits at the beginning and end of the study and complete questionnaires and symptom assessments throughout the study.
  • Record cold symptoms, medications, and other study information using a smartphone application.
  • Provide blood and stool samples during the study.
02

Conditions studied

  • Common Cold
  • Upper Respiratory Tract Infection (URTI)
03

In context

Common Cold

219 studies on the registry are indexed under Common Cold; 23 are open to participants now.

This study's planned enrollment of 160 is close to the median of 150 across 184 interventional studies indexed under Common Cold.

Browse Common Cold studies →

Lead sponsor

Givaudan France Naturals is the lead sponsor of 12 studies on the registry; 3 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 65 Years
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

  • Men and women aged 18 to 65 years.
  • History of at least two upper respiratory tract infections during the previous winter season.
  • between 18 and 30 kg/m².
  • Generally healthy, as determined by the investigator.
  • Women of must have a negative pregnancy test and agree to use an effective method of during the study.
  • Covered by French health insurance.
  • Able and willing to provide written .

Exclusion criteria

Exclusion Criteria:

  • Current or recent upper respiratory tract infection or COVID-19 infection within 2 weeks before enrollment.
  • Acute gastrointestinal infection, including gastroenteritis, within 2 weeks before enrollment.
  • Use of non-steroidal anti-inflammatory drugs (NSAIDs) within 2 weeks before enrollment.
  • Use of systemic antibiotics within 3 months before enrollment.
  • Receipt of any vaccination within 6 weeks before enrollment.
  • Surgery requiring general anesthesia within 1 month before enrollment.
  • History of chronic respiratory disease, including asthma or .
  • Food allergy or chronic/recurrent allergic upper airway conditions requiring regular medical treatment, including moderate to severe allergic rhinitis, hay fever, or chronic rhinosinusitis.
  • Acute lower respiratory tract infection within 6 months before enrollment or ongoing long COVID.
  • Immunodeficiency (including infection) or disease, except stable hypothyroidism.
  • Severe or uncontrolled chronic disease, including cancer, significant liver, pancreatic, biliary, or renal disease, inflammatory bowel disease, or cardiovascular disease requiring intensive medical management.
  • Untreated or inadequately controlled diabetes.
  • History or current diagnosis of periodontitis.
  • Current chemotherapy, therapy, or chronic treatment with or opioids.
  • Specific diets or major dietary changes within 3 months before enrollment, including high-protein, vegan, low-calorie, or low-FODMAP diets, or participation in a weight-loss program.
  • Current use of dietary supplements that may affect immune or gut microbiota parameters, or discontinuation of such supplements less than 6 weeks before enrollment.
  • Current smoking or e-cigarette use, or smoking cessation within 6 months before enrollment.
  • Current drug or alcohol abuse, or a history of abuse within the previous 12 months.
  • Regular consumption of more than 2 alcoholic drinks per day and unwillingness to maintain stable drinking habits during the study.
  • Unwillingness to refrain from using over-the-counter cold remedies, nasal washes or sprays, antihistamines, corticosteroids, or NSAIDs during the study.
  • More than 8 hours per week of vigorous physical activity or planned major changes in physical activity during the study.
  • Any condition or circumstance that, in the investigator's judgment, may place the participant at unacceptable risk or interfere with study participation or interpretation of study results.
  • Current participation in another clinical trial or being in an exclusion period from a previous clinical trial.
  • Pregnant or breastfeeding.
  • Persons deprived of liberty, under legal protection, or unable to provide .
  • Individuals who have reached the regulatory compensation limit for participation in clinical research.
Terms in these criteria, in plain language(9)

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.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

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.

COPD

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

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.

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.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    Immune X

    80 participants who meet the eligibility criteria will be randomized to the experimental arm and will receive Immune X for 16 weeks.

    Dietary Supplement: Immune X

  • Placebo comparator
    Placebo

    80 participants who meet the eligibility criteria will be randomized to the placebo arm and will receive placebo for 16 weeks.

    Other: Placebo

Interventions

  • Dietary supplementImmune X

    500 mg Immune X daily as capsules for 16 weeks.

  • OtherPlacebo

    Matching placebo capsules daily for 16 weeks.

06

What researchers measure

Primary outcomes

  1. Participants With at Least One Clinically Confirmed Cold Event

    Proportion of participants with at least one clinically confirmed cold event.

    Time frame: Week 2 to Week 16

Secondary outcomes

  1. Number of Clinically Confirmed Cold Events

    Mean number of clinically confirmed cold events per participant.

    Time frame: Week 2 to Week 16

  2. Duration of Clinically Confirmed Cold Events

    Duration of clinically confirmed cold events measured in days.

    Time frame: Week 2 to Week 16

  3. Upper Respiratory Symptoms of Clinically Confirmed Cold Events

    Wisconsin Upper Respiratory Symptom Survey (WURSS-24): Zero is equivalent to no symptoms and 7 indicates severe.

    Time frame: Week 2 to Week 16

  4. Cold Symptoms of Clinically Confirmed Cold Events

    Jackson Cold Scale: 0 is equivalent to absent symptoms and 3 indicates severe symptoms

    Time frame: Week 2 to Week 16

  5. Illness-Specific Quality of Life During Cold Events

    Wisconsin Upper Respiratory Symptom Survey (WURSS-24) quality-of-life score: Zero is equivalent to no interference and 7 indicates severe interference.

    Time frame: Week 2 to Week 16

  6. Time to First Clinically Confirmed Cold Event

    Number of days from Day 15 after randomization to the first clinically confirmed cold event.

    Time frame: Week 2 to Week 16

  7. Fatigue

    Chalder Fatigue Questionnaire (CFQ-11) total score: 0 is equivalent to less/better than usual and 33 indicates much more/much worse than usual.

    Time frame: Baseline, Weeks 4, 8, 12, and 16

  8. Use of Rescue Medication During Cold Events

    Number of doses and duration of rescue medication use during cold events.

    Time frame: Week 2 to Week 16

  9. Number of Cold Events (Clinically Confirmed and Unconfirmed)

    Mean number of clinically confirmed and unconfirmed cold events per participant.

    Time frame: Week 2 to Week 16

  10. Adverse Events

    Number of participants with adverse events.

    Time frame: Baseline through Week 16

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

2 registry updates since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 7, 2026
Sites
1 site added — first site in France
Show site
  • CEN Expérimental · Dijon, France
Oct 7, 2026
Start date
Sep 1, 2026→Oct 9, 2026
Oct 7, 2026
Primary completion
Apr 30, 2027→Mar 1, 2027
Oct 7, 2026
Study completion
Apr 30, 2027→Mar 1, 2027
Oct 7, 2026
Show all 2 updates
  1. Oct 13, 2026
    Minor edits only
    + 1 other change: date precision
  2. Oct 7, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in France
    Show site
    • CEN Expérimental · Dijon, France
    Start date Sep 1, 2026→Oct 9, 2026
    Primary completion Apr 30, 2027→Mar 1, 2027
    Study completion Apr 30, 2027→Mar 1, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07787130
Lead sponsor
Givaudan France Naturals
Collaborators
CEN Expérimental
Responsible party
Sponsor
First posted
Aug 26, 2026
Start date
Oct 9, 2026
Primary completion
Mar 1, 2027 (estimated)
Completion
Mar 1, 2027 (estimated)
Last update
Oct 13, 2026

Study contacts

Katja A. Schönenberger, PhD
Contact
katja.schoenenberger@givaudan.com
+41 52 354 01 11
Linda Lopez, PhD
Contact
linda.lopez@givaudan.com
+41 52 354 01 11
Carole Perrin, MD
principal investigator · CEN Expérimental

Oversight

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

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