[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100467475":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":38,"locations":47,"responsibleParty":99,"collaborators":101,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":108,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":42,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":128,"overallStatus":49,"whyStopped":42,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cal-Mag-Butyrate","EXPERIMENTAL","Take oral capsule as directed (600 mg, twice a day for 18 weeks) with or without food.",[13],"Drug: Cal-Mag Butyrate",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo for Cal-Mag-Butyrate","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Cal-Mag Butyrate","Supplements",[9],[26],"Bodybio Calcium Magnesium Butyrate",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Placebo","Only Cal-Mag but no Butyric acid",[15],[32],"Placebo Cal-Mag Butyrate",[34],{"name":35,"affiliation":36,"role":37},"Saurabh Chatterjee, PhD","VA Long Beach Healthcare System, Long Beach, CA","PRINCIPAL_INVESTIGATOR",[39,44],{"name":35,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","(562) 826-8000",null,"saurabhc@hs.uci.edu",{"name":45,"role":40,"phone":41,"phoneExt":42,"email":46},"Jonathan Skupsky","Jonathan.Skupsky@va.gov",[48,64,84],{"facility":36,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Long Beach","California","90822","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-118.18923,33.76696,{"lat":59,"lon":58},[62,63],{"name":35,"role":40,"phone":41,"phoneExt":42,"email":43},{"name":35,"role":37,"phone":42,"phoneExt":42,"email":42},{"facility":65,"status":49,"city":66,"state":67,"zip":68,"country":53,"countryCode":54,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Miami VA Healthcare System, Miami, FL","Miami","Florida","33125",{"type":56,"coordinates":70},[71,72],-80.19366,25.77427,{"lat":72,"lon":71},[75,80],{"name":76,"role":40,"phone":77,"phoneExt":78,"email":79},"Nancy Klimas, MD","305-575-7000","1 4204","nancy.klimas@va.gov",{"name":81,"role":40,"phone":82,"phoneExt":42,"email":83},"Devra Cohen, MPH","3055757648","Devra.cohen@va.gov",{"facility":85,"status":49,"city":86,"state":87,"zip":88,"country":53,"countryCode":54,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"VA Salt Lake City Health Care System, Salt Lake City, UT","Salt Lake City","Utah","84148-0001",{"type":56,"coordinates":90},[91,92],-111.89105,40.76078,{"lat":92,"lon":91},[95],{"name":96,"role":40,"phone":97,"phoneExt":42,"email":98},"Ashok Tuteja, MD","801-582-1565","ashok.tuteja@va.gov",{"type":100,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR",[102,104],{"name":103,"class":6},"Miami VA Healthcare System",{"name":105,"class":6},"VA Salt Lake City Health Care System","100467475","phase-2-ca-mg-butyrate-in-gwi-100467475",false,"NCT05367245","Ca-Mg Butyrate in GWI","Microbiome Targeted Oral Butyrate Therapy in Gulf War Multisymptom Illness","Butyrate","Inclusion Criteria:\n\n* Gulf war era veteran deployed 40 and 70 years old, in good health by medical history prior to 1990 meeting GWI case definition of CDC and Kansas criteria and\n* currently have no exclusionary diagnoses (self- reported) that could reasonably explain the symptoms of their fatiguing illness. The severity of illness is moderate to severe, scoring less than 30 of 100 on the physical domain of VSF36 .\n\nExclusion Criteria:\n\n* Untreated schizophrenia,\n* Untreated bipolar disorder,\n* Untreated delusional disorders,\n* Untreated dementias of any type and\n* active alcoholism or drug abuse.\n* Medical conditions excluded include (i) organ failure, (ii) defined rheumatologic inflammatory disorders, and (iii) transplant.\n* Use of Butyrate in any form in the 3 months prior to study drug, medications that would impact gut motility, diarrhea, chronic pain, and immune function e.g., steroids, (Last 3 months)\n* immunosuppressive drugs or biologic response modifiers within 3 months of study entry will be used as exclusion criteria.\n* Pregnancy, or planned pregnancy in the next 6 months,\n* Body mass index more than 35\n* Specific diets that may have enhanced or enriched fiber or butyrogenic formulations (FODMAP)\n* Medications that could potentially impact immune function in the past one month will be excluded (e.g., steroids, antibiotics, immunosuppressives;\n* Medications containing supplement calcium or magnesium butyrate should not be taken for at least 3 months before study entry.\n* Nutraceuticals that are formulated to impact gut microbiome or immune health) and use of drugs that affect GI motility and use of any antibiotic in the last 2 months.\n* Known allergy to butyrate supplements or their derivatives such as sodium salts or hydroxy derivatives of butyrate and\u002For inactive ingredients of active and placebo soft gelatin will also be excluded.\n* Current evidence of celiac disease or late-stage cirrhosis of the liver, Giardia antigen presence, Clostridium difficile toxin in stool, tissue transglutaminase antibody, recent change in gastrointestinal medications, use of drugs that affects gastrointestinal motility, and use of any antibiotic in the last two months also will be excluded.","ALL","40 Years","70 Years",{"count":118,"type":119},120,"ESTIMATED","INTERVENTIONAL",[122],"PHASE2","The primary objective of this clinical trial is to determine if treatment with Butyrate formulation that consists of butyric acid as calcium and magnesium derivatives (Ca-Mg Butyrate) improves the physical function of men and women Veterans suffering from Gulf War Illness (GWI). The primary outcome measure is a change from baseline on the Short Form Health Survey 36-item (VSF-36), with respect to physical functioning and symptoms. The secondary outcome will focus on the drug's role in (a) restoring gut microbiome and virome, (b) decreasing gastrointestinal disturbances (constipation, diarrhea, pain), (c) decreasing chronic fatigue, (d) decreasing systemic inflammation, and (e) a decrease in cognitive deficits.",[125,126,127],"Gulf War Illness","Chronic Fatigue","Neurocognitive Dysfunction",[129,125,130,131,132,112],"SCFA","GWI","Microbiome","Butyric acid","2025-10-29",{"date":135,"type":136},"2025-10-31","ACTUAL",{"date":138,"type":136},"2024-01-15",{"date":140,"type":119},"2027-03-31",{"name":5,"class":6},3]