[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07611435":3,"trial-entities:NCT07611435":139,"trial-summary:NCT07611435":144},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":41,"secondary_outcomes":46,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":60,"eligibility_criteria":61,"std_ages":65,"locations":68,"central_contacts":121,"overall_officials":122,"references":129,"see_also_links":130},"NCT07611435","DAIT CoFAR-13","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)","NOT_YET_RECRUITING","2032-09-30","2026-07","2026-07-06","2026-07-30","National Institute of Allergy and Infectious Diseases (NIAID)","NIH",true,"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)",null,[19,20],"Alpha-Gal Syndrome","Allergy",[19,22],"Oral Food Challenge","INTERVENTIONAL","DIAGNOSTIC",[26],"PHASE2",{"count":28,"type":29},160,"ESTIMATED",[31,38],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DIAGNOSTIC_TEST","DBFC with 150g of Alpha-gal Knock Out (KO) 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",[36,37],"Sequence 1: KO, then WT","Sequence 2: WT, then KO",{"type":32,"name":39,"description":34,"armGroupLabels":40},"DBFC with 150g of Wild Type (WT) pork",[36,37],[42],{"measure":43,"description":44,"timeFrame":45},"Positive Double Blind Food Challenge (DBFC) result to 150 grams of either alpha-gal knockout (KO) pork or wild type (WT) pork.","A positive challenge will be defined as experiencing symptoms grade 2 or higher on the Consortium for Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions (scale range from 1 to 5, with higher scores indicating a more severe reaction) within 6 hours of ingestion.","At Visit 1 (within 2 months of screening) or Visit 2 (between 8 and 30 days of Visit 1)",[47,50,54],{"measure":48,"description":49,"timeFrame":45},"Alpha-gal sub-phenotype as determined by symptoms resulting from Double Blind Food Challenge (DBFC) to wild-type (WT) pork.","Post-challenge alpha-gal sub-phenotypes as defined by reaction to their first DBFC to WT pork: anaphylaxis, cutaneous-only, or GI-only.",{"measure":51,"description":52,"timeFrame":53},"Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome (GSRS-IBS) scores in response to 150 grams of Knock Out (KO) or Wild Type (WT) pork at each challenge visit","Validated patient-reported outcome measures: gastrointestinal symptoms based on GSRS-IBS score (score range from 15 to 105, with higher scores indicating a worse outcome).","At 7 days following completion of Double Blind Food Challenge (DBFC) at Visit 1 (within 2 months of screening) or Visit 2 (between 8 and 30 days of Visit 1)",{"measure":55,"description":56,"timeFrame":53},"Urticaria Activity Score (UAS7) in response to 150 grams of Knock Out (KO) or Wild Type (WT) pork at each challenge visit.","Validated patient-reported outcome measures: urticaria symptoms based on UAS7 score (score range from 0 to 42, with higher scores indicating a worse outcome).","ALL","12 Years","50 Years",false,{"inclusion":62,"exclusion":63,"raw_text":64},[],[],"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",[66,67],"CHILD","ADULT",[69,87,102,110],{"facility":70,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":84},"Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology","Little Rock","Arkansas","72202","United States",[76,81],{"name":77,"role":78,"phone":79,"email":80},"Aprile Wicker","CONTACT","501-364-1998","wickeraj@archildrens.org",{"name":82,"role":83},"Stacie Jones, MD","PRINCIPAL_INVESTIGATOR",{"lat":85,"lon":86},34.74648,-92.28959,{"facility":88,"city":89,"state":90,"zip":91,"country":74,"contacts":92,"geoPoint":99},"North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology","Chapel Hill","North Carolina","27599",[93,97],{"name":94,"role":78,"phone":95,"email":96},"Morgan Goins","919-445-7031","morgan_goins@med.unc.edu",{"name":98,"role":83},"Sarah McGill, MD, MSc",{"lat":100,"lon":101},35.9132,-79.05584,{"facility":103,"city":104,"state":105,"zip":106,"country":74,"geoPoint":107},"Vanderbilt University Medical Center: Division of Pediatric Allergy, Immunology, and Pulmonary Medicine","Nashville","Tennessee","37232",{"lat":108,"lon":109},36.16589,-86.78444,{"facility":111,"city":112,"state":113,"zip":114,"country":74,"contacts":115,"geoPoint":118},"University of Virginia Health System: Division of Asthma & Immunology","Charlottesville","Virginia","22908",[116],{"name":117,"role":83},"Jeffrey Wilson, MD",{"lat":119,"lon":120},38.02931,-78.47668,[],[123,126],{"name":124,"affiliation":103,"role":125},"Leonard Bacharier, M.D.","STUDY_CHAIR",{"name":127,"affiliation":128,"role":125},"Rachel Robison, M.D.","Vanderbilt University Medical Center: Division of Allergy, Pulmonary and Critical Care Medicine",[],[131,134,136],{"label":132,"url":133},"Consortium of Food Allergy Research (CoFAR)","https:\u002F\u002Fwww.cofargroup.org\u002F",{"label":13,"url":135},"https:\u002F\u002Fwww.niaid.nih.gov\u002F",{"label":137,"url":138},"Division of Allergy, Immunology, and Transplantation (DAIT)","https:\u002F\u002Fwww.niaid.nih.gov\u002Fabout\u002Fdait",{"nct_id":4,"conditions":140,"biomarkers":142},[141],"Allergy to red meat",[143],"IgE",{"nct_id":4,"found":15,"summary":145,"prompt_version":155},{"design":146,"status":147,"heading":148,"summary":149,"follow_up":150,"word_count":151,"commitments":152,"compensation":153,"drugs_mentioned":154},"This is a randomized, double-blind study involving 160 participants. Each participant will try both types of pork, serving as their own comparison.","completed","Study on Alpha-Gal Syndrome and Pork Challenges","This study is looking at how people with Alpha-Gal Syndrome (AGS), a type of allergy, react to different kinds of pork. Researchers want to see if eating pork where the alpha-gal sugar has been removed (alpha-gal Knock Out or KO pork) causes fewer allergic reactions compared to regular pork (Wild Type or WT pork). You would eat both types of pork on separate days, with at least 8 days in between. The study is for people aged 12 to 50 who have symptoms of Alpha-Gal Syndrome. The main goal is to find out if KO pork is less likely to cause a positive allergic reaction than WT pork.","Your reactions to the pork challenges will be measured at Visit 1 (within 2 months of screening) or Visit 2 (between 8 and 30 days of Visit 1).",108,"You would participate in two oral food challenges, eating 150 grams of pork on each occasion. There will be at least an 8-day break between these challenges.","Not stated in the trial record.",[],"v2"]