Effect of Immune X on Common Cold Incidence in Healthy Adults

NCT07787130 | Not Yet Recruiting

• 2 other identifiers: C17752026-A00903-48
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Common Cold; Upper Respiratory Tract Infection (URTI)

Outcome Measures

Primary Outcomes (1)

• Participants With at Least One Clinically Confirmed Cold Event

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

  Week 2 to Week 16

Secondary Outcomes (10)

• Number of Clinically Confirmed Cold Events

  Week 2 to Week 16

• Duration of Clinically Confirmed Cold Events

  Week 2 to Week 16

• Upper Respiratory Symptoms of Clinically Confirmed Cold Events

  Week 2 to Week 16

• Cold Symptoms of Clinically Confirmed Cold Events

  Week 2 to Week 16

• Illness-Specific Quality of Life During Cold Events

  Week 2 to Week 16

Study Arms (2)

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.

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.

Other: Placebo

Interventions

Immune X DIETARY_SUPPLEMENT

500 mg Immune X daily as capsules for 16 weeks.

Immune X

Placebo OTHER

Matching placebo capsules daily for 16 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Givaudan France Naturals: lead
• CEN Expérimental: collaborator

MeSH Terms

Conditions

Common Cold; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Carole Perrin, MD

  CEN Expérimental

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katja A. Schönenberger, PhD

CONTACT

+41 52 354 01 11; katja.schoenenberger@givaudan.com

Linda Lopez, PhD

CONTACT

+41 52 354 01 11; linda.lopez@givaudan.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-08