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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
160
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
Number of Clinically Confirmed Cold Events
Mean number of clinically confirmed cold events per participant.
Time frame: Week 2 to Week 16
Duration of Clinically Confirmed Cold Events
Duration of clinically confirmed cold events measured in days.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 2 to Week 16
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
Adverse Events
Number of participants with adverse events.
Time frame: Baseline through Week 16
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