Common ColdCELFINCT07787130
Effect of Immune X on Common Cold Incidence in Healthy Adults
A study testing Immune X in people with Common Cold and Upper Respiratory Tract Infection (URTI), run by Givaudan France Naturals at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Common Cold, Upper Respiratory Tract Infection (URTI)
- What is being tested?
- Immune X
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 9 Oct 2026to 1 Mar 2027
- Phase
- Interventional
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged 18 to 65 years.
- History of at least two upper respiratory tract infections during the previous winter season.
- Body mass index between 18 and 30 kg/m².
- Generally healthy, as determined by the investigator.
- Women of childbearing potential must have a negative pregnancy test and agree to use an effective method of contraception during the study.
- Covered by French health insurance.
- Able and willing to provide written informed consent.
Who cannot join
- 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.
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- History of chronic respiratory disease, including asthma or chronic obstructive pulmonary disease.
- 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 HIV infection) or autoimmune 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, immunosuppressive therapy, or chronic treatment with corticosteroids 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 informed consent.
- Individuals who have reached the regulatory compensation limit for participation in clinical research.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CEN Expérimental
Dijon, Côte-d'Or, 21000
Amandine Fry, +33 3 80 68 05 05, contact@groupecen.com
About this study
Official title: The Effect of Immune X on the Incidence of the Common Cold in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled Trial
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?
Read more
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.
- Being tested
- Immune X, Placebo
- Medical subject headings
- Common Cold, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune XDietary supplement
500 mg Immune X daily as capsules for 16 weeks.
PlaceboOther
Matching placebo capsules daily for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Immune X | Experimental | 80 participants who meet the eligibility criteria will be randomized to the experimental arm and will receive Immune X for 16 weeks. Receives: Dietary Supplement: Immune X |
| Placebo | Placebo comparator | 80 participants who meet the eligibility criteria will be randomized to the placebo arm and will receive placebo for 16 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With at Least One Clinically Confirmed Cold Event
Proportion of participants with at least one clinically confirmed cold event.
Measured: Week 2 to Week 16
Secondary outcomes (10)
Number of Clinically Confirmed Cold Events
Mean number of clinically confirmed cold events per participant.
Measured: Week 2 to Week 16
Duration of Clinically Confirmed Cold Events
Duration of clinically confirmed cold events measured in days.
Measured: Week 2 to Week 16
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.
Measured: Week 2 to Week 16
Cold Symptoms of Clinically Confirmed Cold Events
Jackson Cold Scale: 0 is equivalent to absent symptoms and 3 indicates severe symptoms
Measured: Week 2 to Week 16
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.
Measured: Week 2 to Week 16
Time to First Clinically Confirmed Cold Event
Number of days from Day 15 after randomization to the first clinically confirmed cold event.
Measured: Week 2 to Week 16
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.
Measured: Baseline, Weeks 4, 8, 12, and 16
Use of Rescue Medication During Cold Events
Number of doses and duration of rescue medication use during cold events.
Measured: Week 2 to Week 16
Number of Cold Events (Clinically Confirmed and Unconfirmed)
Mean number of clinically confirmed and unconfirmed cold events per participant.
Measured: Week 2 to Week 16
Adverse Events
Number of participants with adverse events.
Measured: Baseline through Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start9 Oct 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common ColdStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Givaudan France Naturals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CEN Expérimental
- Responsible party
- Sponsor
- Investigators
- Carole Perrin, MD, Principal investigator, CEN Expérimental
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787130
- Sponsor's protocol ID
- C1775
- Other IDs
- 2026-A00903-48
- Acronym
- CELFI
- Status last verified
- Oct 2026
- First submitted
- 17 Aug 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided