[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Givaudan France Naturals\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"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":22,"type":23},160,"ESTIMATED","INTERVENTIONAL",[26],"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.",[29,30],"Common Cold","Upper Respiratory Tract Infection (URTI)","RECRUITING","2026-10-09",{"date":34,"type":35},"2026-10-13","ACTUAL",{"date":32,"type":35},{"date":38,"type":23},"2027-03-01",{"name":40,"class":41},"Givaudan France Naturals","INDUSTRY",""]