[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653414":3},{"organization":4,"outcomesModule":7,"designInfo":47,"detailedDescription":46,"studyPopulation":46,"armGroups":57,"interventions":70,"overallOfficials":79,"centralContacts":84,"locations":93,"responsibleParty":112,"collaborators":114,"id":117,"slug":118,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":125,"sex":126,"minAge":127,"maxAge":128,"enrollmentInfo":129,"targetDuration":46,"studyType":132,"phases":133,"briefSummary":135,"conditions":136,"keywords":46,"overallStatus":95,"whyStopped":46,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":143,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Givaudan France Naturals","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":46},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,17,20,23,26,29,32,36,39,42],{"measure":15,"description":16,"timeFrame":12},"Number of Clinically Confirmed Cold Events","Mean number of clinically confirmed cold events per participant.",{"measure":18,"description":19,"timeFrame":12},"Duration of Clinically Confirmed Cold Events","Duration of clinically confirmed cold events measured in days.",{"measure":21,"description":22,"timeFrame":12},"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.",{"measure":24,"description":25,"timeFrame":12},"Cold Symptoms of Clinically Confirmed Cold Events","Jackson Cold Scale: 0 is equivalent to absent symptoms and 3 indicates severe symptoms",{"measure":27,"description":28,"timeFrame":12},"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.",{"measure":30,"description":31,"timeFrame":12},"Time to First Clinically Confirmed Cold Event","Number of days from Day 15 after randomization to the first clinically confirmed cold event.",{"measure":33,"description":34,"timeFrame":35},"Fatigue","Chalder Fatigue Questionnaire (CFQ-11) total score: 0 is equivalent to less\u002Fbetter than usual and 33 indicates much more\u002Fmuch worse than usual.","Baseline, Weeks 4, 8, 12, and 16",{"measure":37,"description":38,"timeFrame":12},"Use of Rescue Medication During Cold Events","Number of doses and duration of rescue medication use during cold events.",{"measure":40,"description":41,"timeFrame":12},"Number of Cold Events (Clinically Confirmed and Unconfirmed)","Mean number of clinically confirmed and unconfirmed cold events per participant.",{"measure":43,"description":44,"timeFrame":45},"Adverse Events","Number of participants with adverse events.","Baseline through Week 16",null,{"allocation":48,"interventionModel":49,"interventionModelDescription":46,"primaryPurpose":50,"observationalModel":46,"timePerspective":46,"maskingInfo":51},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":52,"maskingDescription":46,"whoMasked":53},"TRIPLE",[54,55,56],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[58,64],{"label":59,"type":60,"description":61,"interventionNames":62},"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.",[63],"Dietary Supplement: Immune X",{"label":65,"type":66,"description":67,"interventionNames":68},"Placebo","PLACEBO_COMPARATOR","80 participants who meet the eligibility criteria will be randomized to the placebo arm and will receive placebo for 16 weeks.",[69],"Other: Placebo",[71,75],{"type":72,"name":59,"description":73,"armGroupLabels":74,"otherNames":46},"DIETARY_SUPPLEMENT","500 mg Immune X daily as capsules for 16 weeks.",[59],{"type":76,"name":65,"description":77,"armGroupLabels":78,"otherNames":46},"OTHER","Matching placebo capsules daily for 16 weeks.",[65],[80],{"name":81,"affiliation":82,"role":83},"Carole Perrin, MD","CEN Expérimental","PRINCIPAL_INVESTIGATOR",[85,90],{"name":86,"role":87,"phone":88,"phoneExt":46,"email":89},"Katja A. Schönenberger, PhD","CONTACT","+41 52 354 01 11","katja.schoenenberger@givaudan.com",{"name":91,"role":87,"phone":88,"phoneExt":46,"email":92},"Linda Lopez, PhD","linda.lopez@givaudan.com",[94],{"facility":82,"status":95,"city":96,"state":97,"zip":98,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":106,"contacts":107},"RECRUITING","Dijon","Côte-d'Or","21000","France","FR",{"type":102,"coordinates":103},"Point",[104,105],5.01391,47.31344,{"lat":105,"lon":104},[108],{"name":109,"role":87,"phone":110,"phoneExt":46,"email":111},"Amandine Fry","+33 3 80 68 05 05","contact@groupecen.com",{"type":113,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR",[115],{"name":82,"class":116},"UNKNOWN","100653414","effect-of-immune-x-on-common-cold-incidence-in-healthy-adults-100653414",false,"NCT07787130","Effect of Immune X on Common Cold Incidence in Healthy Adults","The Effect of Immune X on the Incidence of the Common Cold in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled Trial","CELFI","Inclusion Criteria:\n\n* Men and women aged 18 to 65 years.\n* History of at least two upper respiratory tract infections during the previous winter season.\n* Body mass index between 18 and 30 kg\u002Fm².\n* Generally healthy, as determined by the investigator.\n* Women of childbearing potential must have a negative pregnancy test and agree to use an effective method of contraception during the study.\n* Covered by French health insurance.\n* Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Current or recent upper respiratory tract infection or COVID-19 infection within 2 weeks before enrollment.\n* Acute gastrointestinal infection, including gastroenteritis, within 2 weeks before enrollment.\n* Use of non-steroidal anti-inflammatory drugs (NSAIDs) within 2 weeks before enrollment.\n* Use of systemic antibiotics within 3 months before enrollment.\n* Receipt of any vaccination within 6 weeks before enrollment.\n* Surgery requiring general anesthesia within 1 month before enrollment.\n* History of chronic respiratory disease, including asthma or chronic obstructive pulmonary disease.\n* Food allergy or chronic\u002Frecurrent allergic upper airway conditions requiring regular medical treatment, including moderate to severe allergic rhinitis, hay fever, or chronic rhinosinusitis.\n* Acute lower respiratory tract infection within 6 months before enrollment or ongoing long COVID.\n* Immunodeficiency (including HIV infection) or autoimmune disease, except stable hypothyroidism.\n* Severe or uncontrolled chronic disease, including cancer, significant liver, pancreatic, biliary, or renal disease, inflammatory bowel disease, or cardiovascular disease requiring intensive medical management.\n* Untreated or inadequately controlled diabetes.\n* History or current diagnosis of periodontitis.\n* Current chemotherapy, immunosuppressive therapy, or chronic treatment with corticosteroids or opioids.\n* 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.\n* Current use of dietary supplements that may affect immune or gut microbiota parameters, or discontinuation of such supplements less than 6 weeks before enrollment.\n* Current smoking or e-cigarette use, or smoking cessation within 6 months before enrollment.\n* Current drug or alcohol abuse, or a history of abuse within the previous 12 months.\n* Regular consumption of more than 2 alcoholic drinks per day and unwillingness to maintain stable drinking habits during the study.\n* Unwillingness to refrain from using over-the-counter cold remedies, nasal washes or sprays, antihistamines, corticosteroids, or NSAIDs during the study.\n* More than 8 hours per week of vigorous physical activity or planned major changes in physical activity during the study.\n* 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.\n* Current participation in another clinical trial or being in an exclusion period from a previous clinical trial.\n* Pregnant or breastfeeding.\n* Persons deprived of liberty, under legal protection, or unable to provide informed consent.\n* Individuals who have reached the regulatory compensation limit for participation in clinical research.",true,"ALL","18 Years","65 Years",{"count":130,"type":131},160,"ESTIMATED","INTERVENTIONAL",[134],"NA","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:\n\n* Does Immune X reduce the proportion of participants who experience at least one clinically confirmed common cold event during the study period?\n* Does Immune X affect the number, duration, and severity of common cold events?\n\nResearchers will compare Immune X to a placebo (a look-alike capsule containing inactive ingredients) to see if Immune X helps prevent common cold events.\n\nParticipants will:\n\n* Take Immune X or placebo daily for 16 weeks during the winter season.\n* Attend study visits at the beginning and end of the study and complete questionnaires and symptom assessments throughout the study.\n* Record cold symptoms, medications, and other study information using a smartphone application.\n* Provide blood and stool samples during the study.",[137,138],"Common Cold","Upper Respiratory Tract Infection (URTI)","2026-10-09",{"date":141,"type":142},"2026-10-13","ACTUAL",{"date":139,"type":142},{"date":145,"type":131},"2027-03-01",{"name":5,"class":6},1]