[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alpha-gal-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alpha-gal-syndrome":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100638442","phase-2-beginning-to-assess-an-appropriate-control-for-oral-food-challenges-in-alpha-gal-syndrome-cofar-13---beacon4ag-100638442",false,"NCT07611435","Beginning to Assess an Appropriate CONtrol for Oral Food Challenges in Alpha-Gal Syndrome (CoFAR-13) - BeACON4AG","Beginning to Assess an Appropriate CONtrol for Oral Food Challenges in Alpha-Gal Syndrome (CoFAR-13)","BeACON4AG","Inclusion Criteria:\n\n1. Able to understand and provide informed consent and\u002For have a parent or guardian able to understand and provide informed consent. Participants 12-17 years old must be able to provide assent\n2. Participants who are willing to complete study procedures and follow-up\n3. Have clinical history consistent with Alpha-gal Syndrome (AGS)\n4. Have alpha-gal-specific Immunoglobin E (IgE) \\>= 0.1KU\u002FL at screening\n5. Report reaction consistent with AGS within the previous 24 months (prior to enrollment)\n6. If with reproductive potential, agree to be abstinent or use an US Food and Drug Administration (FDA) approved method of birth control for the duration of the study\n7. Willing to be trained on the proper use of a device for the self-administration of epinephrine (i.e., autoinjector or intra-nasal spray) and willing to have two doses available for the duration of the study\n\nExclusion Criteria:\n\n1. Unwilling to consume pork (native\u002Fwild type or genetically modified to no longer contain alpha-gal) during Double Blind Food Challenge (DBFC)\n2. Have underlying health conditions suggesting that participants should not undergo an oral food challenge, including conditions that may be exacerbated by oral food challenge or treatment with epinephrine (e.g., history of ischemic heart disease, uncontrolled asthma, or cardiac arrhythmia)\n3. Likely to move away from the study site prior to completion of follow up or do not have regular access to a phone\n4. Have a history of severe anaphylaxis in response to pork or alpha-gal ingestion, defined as neurologic compromise or requiring intubation or cardiovascular compromise defined as myocardial infarction or other clinically significant cardiovascular events\n5. Unwilling or unable to stop use of medications that may interfere with oral food challenge interpretation, reaction, or treatment for 5 half-lives prior to the challenge (e.g., antihistamines, beta blockers, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)\n6. Have used systemic immunomodulators (including biologics and monoclonal antibody therapy) within 6 months before study entry\n7. Have underlying health conditions that may increase the chance of false positive challenges (e.g., inflammatory bowel disease, chronic urticaria, systemic mastocytosis, and mast cell activating syndrome)\n8. Have used systemic steroids within 4 weeks of study entry\n9. Have used any investigational agent within 6 months of study entry\n10. Are on build-up of immunotherapy such as Antigen-based Immunotherapy (AIT), Oral Immunotherapy (OIT), Sublingual Immunotherapy (SLIT), or Epicutaneous Immunotherapy (EPIT)\n11. Have reacted to mammalian products with onset of symptoms within 30 minutes of oral ingestion\n12. Have current, diagnosed, mental illness or current, diagnosed or self-reported drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements\n13. Are pregnant or plan to become pregnant during the course of the study\n14. Have past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, and\u002For may impact the quality or interpretation of the data obtained from the study","ALL","12 Years","50 Years",{"count":21,"type":22},160,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a multisite, randomized, double-blind, controlled cross-over trial with detailed characterization of participants with varying clinical sub-phenotypes of Alpha-gal Syndrome (AGS) who are then evaluated by oral food challenges with alpha-gal Knock Out (KO) pork versus Wild Type (WT) pork. Each participant will serve as their own control and ingest both alpha-gal-KO and WT pork on different days, with a minimum of an 8-day washout period between oral food challenges.\n\nThe primary objective is to determine whether the odds of positive challenges among participants with suspected alpha-gal syndrome are lower with alpha-gal Knock Out (KO) pork as compared to Wild Type (WT) pork during Double Blind Food Challenge (DBFC)",[28,29],"Alpha-Gal Syndrome","Allergy",[28,31],"Oral Food Challenge","NOT_YET_RECRUITING","2026-05-29",{"date":35,"type":36},"2026-06-02","ACTUAL",{"date":38,"type":22},"2026-06-15",{"date":40,"type":22},"2032-09-30",{"name":42,"class":43},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",4,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":5},"100606605","the--gal-syndrome---investigating-immune-reactions-to-tick-bites-100606605","NCT07177729","The α-gal Syndrome - Investigating Immune Reactions to Tick Bites","The α-gal Syndrome - Investigating Immune Reactions to Tick Bites Leading to Inflammation and Allergic Sensitization","ImmunoGal","Inclusion criteria:\n\n* Individuals aged ≥ 18 years, Male and Female.\n* Experience of a tick bite: the tick has been removed less than 48 hours ago, or the tick is still attached to the skin and can be removed on site by the study nurse.\n* Tick available for analysis.\n* Informed consent signed.\n\nExclusion criteria:\n\n* Individuals \\\u003C 18 years of age, Male or Female.\n* Individuals with an acute viral\u002Fbacterial inflammation.\n* Individuals with an immune deficiency or under immunosuppressive treatments.\n* Individuals in receipt with immunotherapy with omalizumab.\n* Individuals with neurological diseases \u002F impaired cognitive disorder.",true,"18 Years",{"count":56,"type":22},100,"OBSERVATIONAL","Tick bites can transmit pathogens, but they can also induce a food allergy to mammalian meat. The goal of this clinical trial is to follow immune response and antibody build-up in individuals bitten by a tick. Participants are invited to enroll within 48 hours after the tick removal and donate some blood. The tick is also collected and analysed. Researchers will then try to answer the following questions:\n\n* Was the tick infected with parasites?\n* Did the participant make antibodies against tick proteins or tick-borne parasites?\n* Did the participant develop IgE antibodies against the alpha-Gal sugar? The alpha-Gal sugar is present on mammalian meat, and ticks can transmit the alpha-Gal sugar to the host during their blood meal. Humans recognize the alpha-Gal sugar as foreign and some individuals will build IgE antibodies in response. These IgE antibodies against alpha-Gal can lead to a food allergy to red meat, also known as alpha-Gal syndrome.\n\nResearchers will compare a group of participants that develop IgE against the alpha-Gal sugar with participants that will not. They want to find out if there are specific immune features that differentiate the 2 groups.\n\nParticipants will:\n\n* Enroll after a recent tick bite within 48 hours after tick removal: they will be asked to donate some blood and fill out a questionnaire.\n* Visit the clinic 4 to 6 weeks later for a follow-up sample and questionnaire.\n* Visit the clinic 3 months after the tick bite for allergy tests if they have been selected for this 3rd visit.",[28],[61,62,63,64],"Tick-borne diseases","Tick bites","alpha-Gal syndrome","immuno-phenotyping","RECRUITING","2026-03-24",{"date":68,"type":36},"2026-03-30",{"date":70,"type":36},"2025-07-01",{"date":72,"type":22},"2027-02",{"name":74,"class":75},"Luxembourg Institute of Health","OTHER_GOV"]