[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gulf-war-illness\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gulf-war-illness":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,43,73,104,129,159,184,203,228],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100468133","nih-investigative-deep-phenotyping-study-of-gulf-war-veteran-health-project-nih-in-depth-100468133",false,"NCT05375812","NIH Investigative Deep Phenotyping Study of Gulf War Veteran Health (Project NIH IN-DEPTH)","* INCLUSION CRITERIA:\n\nInclusion criteria for all veterans:\n\n* Ability to provide informed consent\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Age 48-70 at time of enrollment into VA IN-DEPTH Study\n* Veterans who were deployed to Gulf Region ODS\u002FS between August 1990 - June 1991.\n* Self-reported completion of at least the seventh grade of school.\n* Fluency in speaking, reading, and understanding English.\n* Underwent screening as part of the VA IN-DEPTH study and were unanimously determined to be eligible by the IN-DEPTH Adjudication Committee.\n* Agree not to smoke in the 4 hours prior to CPET procedure\n\nEXCLUSION CRITERIA:\n\nExclusion criteria for all veterans:\n\n* Current or past psychotic disorder including depression with psychosis, bipolar disorder with psychotic symptoms and schizophrenia\n* Current DSM-5-defined major depression disorder, generalized anxiety disorder, posttraumatic stress disorder, panic disorder, or obsessive-compulsive disorder unless managed for more than six months with a stable treatment regimen\n* Current or past substance use disorder within last five years as diagnosed on the Structured Clinical Interview for DSM-5 (SCID-5). Prior or prescription marijuana use within the past five years will not be an exclusion.\n* Current suicidal ideation\n* History of head injury leading to moderate or severe traumatic brain injury, as detailed by loss of consciousness for greater than 30 minutes, a Glasgow Coma Score of 12 or less at the time of injury, post-traumatic amnesia greater than one day, or brain-scan changes related to a head injury. Persons having a history of mild TBI (mTBI) will not be excluded.\n* Women who are pregnant, breastfeeding, or are within one-year post-partum.\n* Current or previous malignancy. A history of malignancy that has fully resolved with surgical resection only (e.g. no chemotherapy, radiation therapy, or immunotherapy) will be allowed.\n* Current systemic immunologic disorders (e.g. Type 1 diabetes, rheumatoid arthritis). Local immunological disorder (e.g. atopic dermatitis, stable autoimmune thyroid disease) and allergic disorders will be allowed.\n* Current or previous long-term immune suppressive therapy. Systemic steroid use, even short-term, must not have been used within the month prior to enrollment\n* Any medical condition that would make the study procedures risky for the participant (e.g. congestive heart failure, coronary artery disease, chronic obstructive pulmonary disease, severe osteoarthritis, exercise-induced angina and poorly controlled asthma).\n* Active participation in a clinical protocol (e.g. anti-inflammatory drug intervention study) which includes an intervention that may affect the results of the current study.\n* Inability to perform the bicycling exercise task. (e.g. coronary artery disease, not having a lower limb, disabling stroke)\n* Not willing to allow for research data and samples to be shared broadly with other researchers.\n* Symptom severity that makes it impossible for the volunteer to travel to NIH for extended inpatient evaluation\n* Use of medications with a high-risk for withdrawal-related complications (i.e. long-acting opiates or benzodiazepines).\n\nAdditional Exclusion criteria for participants undergoing TMS:\n\n\\- Pacemaker, implanted pump, stimulator, cochlear implant or metal objects inside the eye or skull.\n\nParticipants with unconfirmed metal may have further evaluation to rule out metal in the eye or skull.\n\nParticipants without metal after evaluation may proceed to TMS.\n\n\\- A personal history of seizure disorder\n\nAdditional Exclusion criteria for participants undergoing MRI:\n\n\\- Metal in the body which would make having an MRI scan unsafe, such as pacemakers, stimulators, pumps, aneurysm clips, metallic prostheses, artificial heart valves, cochlear implants or shrapnel fragments, or having a history of being a welder or metal worker, since small metal fragments may be in the eye. Participants with unconfirmed metal may have further evaluation to rule out metal in the eye\n\nor skull. Participants without metal after evaluation may proceed to MRI.\n\n* Substantial claustrophobia\n* Inability to lie on back for up to 2 hours\n\nAdditional Exclusion criteria for Healthy Veteran Controls:\n\n\\- Meets modified Kansas criteria for GWI.",true,"ALL","48 Years","70 Years",{"count":20,"type":21},85,"ESTIMATED","OBSERVATIONAL","Background:\n\nGulf War illness (GWI) affects up to 210,000 U.S. veterans who served in the Middle East during the Gulf War in 1990-1991. Symptoms include fatigue, muscle and joint pain, forgetfulness, headaches, rashes, and sleep disturbances. Routine exams cannot determine the cause of GWI. Researchers need more information to understand this disease.\n\nObjective:\n\nThis natural history study will look for differences in Gulf War veterans who experienced GWI and those who did not.\n\nEligibility:\n\nGulf War veterans with GWI. Healthy Gulf War veterans who do not have GWI are also needed.\n\nDesign:\n\nParticipants will stay in the NIH Clinical Center as an inpatient for 2 weeks. They will undergo many tests.\n\nBlood will be drawn many times throughout the study. Participants will also give urine, saliva, and stool samples.\n\nScans to measure the brain, leg muscles, bone density and body mass will be done.\n\nThey will have an exercise stress test and muscle strength tests.\n\nThey will have a sleep study. They will have tests to look at how well the brain, heart and lungs are working.\n\nParticipants will sleep in a specialized room that measures the amount of oxygen they use and the carbon dioxide they produce on four consecutive nights.\n\nA sample of fluid will be collected from inside the spine.\n\nParticipants will take many surveys. Some will ask about their activities. Some will be about emotional and mental health. Some will be about thinking, memory, and behavior.\n\nOptional tests include other imaging scans and testing the autonomic nervous system. Samples of skin and muscle may be taken.\n\nAfter discharge, participants will wear activity monitors for 14 days. They will keep a diary of their symptoms, including fatigue, pain, and sleep, while wearing the monitors.",[25],"Gulf War Illness",[27,28,29],"Veteran","Gwi (Gulf War Illness)","Natural History","RECRUITING","2026-06-27",{"date":33,"type":34},"2026-06-30","ACTUAL",{"date":36,"type":34},"2023-04-16",{"date":38,"type":21},"2030-12-31",{"name":40,"class":41},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":42},"100502333","phase-2-resistant-potato-starch-to-alleviate-gwi-100502333","NCT05820893","Resistant Potato Starch to Alleviate GWI","BCCMA: Targeting Gut-Microbiome in Veterans Deployment Related Gastrointestinal and Liver Diseases; CMA5- Functional Metagenomics in GWI-related Gut Dysfunction","Inclusion Criteria:\n\n1. Ability to provide informed written consent\n2. Willing to comply with all study procedures and be available for the duration of the study (including providing stool samples)\n3. Meeting the modified Kansas GWI case definition\\* with gut symptoms endorsed\n4. Deployed to Persian Gulf during Operations Desert Storm or Desert Shield56.Aged 50-85 years old\n\n   * Moderate to severe GWI symptoms lasting at least 6 months in a minimum of three of the six symptom domains (one of which must be fatigue). The symptom domains are:\n\n     * Pain (joint pain, muscle pain)\n     * Gastrointestinal (diarrhea, nausea, vomiting, cramping)\n     * Respiratory (persistent cough, wheezing)\n     * Skin (rashes)\n     * Fatigue (sleep problems, fatigue)\n     * Neurologic (memory problems, headaches, dizziness, mood changes)\n\nExclusion Criteria:\n\n1. A Known SARS-CoV-2 infection in the last 60 days and\u002For with a diagnosis of post-acute sequelae of COVID-19 (PASC, sometimes called long COVID) defined as COVID-19 symptoms lasting for greater than 6 months.\n2. Subjects identified as, or appearing to, lack consent capacity\n3. Alcohol abuse (greater than 14 drinks per week for men and 7 drinks per week for women)\n4. Use of investigational drugs, biologics, or devices within 30 days prior to randomization.\n5. Individuals who are pregnant, lactating or planning on becoming pregnant during the study.\n6. Diagnosed inflammatory bowel disease, Crohn's disease, or Celiac's disease\n7. Uncontrolled\u002Funtreated hypothyroidism\n8. Previous gastrointestinal surgery (colorectal surgery, gastric bypass, intestinal resection)\n9. Systemic antibiotics in the last 30 days\n10. Fecal microbiota transplant in the last 30 days\n11. Active dysphagia\n12. Allergies to any of the ingredients in MSPrebiotic\n13. Use of immunomodulatory medications in the last 30 days\n14. Any other factor, condition, or medication not listed above the Investigators believe will affect the response in the gut or the interpretation of results.","50 Years","85 Years",{"count":53,"type":21},52,"INTERVENTIONAL",[56],"PHASE2","Gulf War Illness (GWI) affects an estimated 25-32% of the over 700,000 coalition troops deployed to the Persian Gulf as part of the First Gulf War. GWI causes a range of pain, fatigue, gastrointestinal, skin, neurologic, and respiratory symptoms. New treatments to reduce GWI-associated morbidity are critically needed. Research suggests a role for the gastrointestinal microbiome in mediating health, including through impacting metabolism and immunity. The disruption of this microbiome plays a role in multiple diseases, and preliminary data suggest that Veterans with GWI have altered gut microbiota. The investigators will evaluate the effectiveness of a dietary fiber prebiotic supplement intervention on improving the quality of life of Veterans with GWI.",[25],[60,25,61,62],"Persian Gulf Syndrome","Veterans","Gastrointestinal Microbiome","2026-05-01",{"date":65,"type":34},"2026-05-06",{"date":67,"type":34},"2025-02-03",{"date":69,"type":21},"2028-06-30",{"name":71,"class":72},"VA Office of Research and Development","FED",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":54,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":42},"100617968","machine-learning-in-guiding-rtms-treatment-for-gwi-related-headaches-and-body-pain-100617968","NCT07325513","Machine Learning in Guiding rTMS Treatment for GWI-Related Headaches and Body Pain","SVM - GWI","Inclusion Criteria:\n\n* Male or female\n* Veteran or active military personnel\n* Between the ages of 18 and 65 years old\n* Served in the Persian Gulf region for at least 30 consecutive days between August 1, 1990, and July 31, 1991\n* Meets the CDC Criteria for GWVI (GWI), with symptoms starting during or after the 1990-1991 Persian Gulf deployment. Symptoms must be present for at least 6 months prior to enrollment in the study. Symptoms must be present in at least 2 of the 3 categories of fatigue, musculoskeletal, and mood cognitive.\n* Meets the Kansas Criteria for GWVI (GWI), with symptoms starting during or after the 1990-1991 Persian Gulf deployment. Symptoms must be present for at least 6 months prior to enrollment in the study. Qualifying symptoms must be at least moderate in severity and\u002For multiple symptoms must be present within at least 3 of 6 categories consisting of fatigue\u002Fsleep, neurological\u002Fcognitive\u002Fmood, pain, respiratory, gastroenterological, and dermatological symptomology.\n* Average Overall Daily Muscle Pain Intensity ≥3 on a 0-10 NPRS, present for at least 6 months\n* Average Overall Daily Extremities Joint Pain Intensity ≥3 on a 0-10 NPRS, present for at least 6 months\n* Average Headache Exacerbation Intensity ≥3 on a 0-10 NPRS, with headaches occurring for at least 6 months\n* Headache Exacerbation\u002Fattack ≥ 1 time per week with the average intensity ≥3 on a 0-10 NPS, lasting \\> 1 hour in the past three months\n* International Headache Society Criteria for Migraine Headache without aura\n\nExclusion Criteria:\n\n* Children under the age of 18\n* Pregnant women\n* Individuals with cognitive\u002Fdecisional impairment\n* Non-English speaking individuals\n* Prisoners of War\n* Incarcerated individuals\n* VA employees - including VA paid, IPA, or WOC\n* Students of the institution or of the investigator\n* Patients with cancer\n* History of pacemaker implant\n* Presence of ferromagnetic material (e.g., bullet fragment, shrapnel, device implant) in the brain or body that will prohibit the patients from having a brain MRI\n* History of dementia, major psychiatric diseases, or life-threatening diseases\n* Presence of any other chronic neuropathic pain states such as Complex Regional Pain Syndrome or Painful Peripheral Neuropathy\n* Known diagnosis of moderate to severe osteoarthritis and\u002For rheumatologic joint pain prior to the GWI deployment\n* Low back pain with mechanical origins such as lumbar radiculopathy or radiculitis or lumbar facet arthropathy\n* Concurrent conditions, like lupus, that can produce symptoms compatible with GWVI\n* History of seizure\n* Pending litigation\n* History of Traumatic Brain Injury-related headaches\n* Chronic Tension or Cluster Headache. However, subjects with occasional tension headaches (less than once every three months and lasting no more than 24 hours) will not be excluded from the study.\n* Ongoing Cognitive Rehabilitation or Treatment of PTSD\n* Recent exacerbation of anxiety disorder symptoms, active substance dependence, and\u002For current psychotic symptoms\n* Ongoing suicidal\u002Fhomicidal ideation or recent (in the past 6 months) suicidal attempts\n* Patients who receive any narcotic-based analgesic, topical analgesics over the affected site, steroid and local anesthetic injection, anticonvulsants, and antipsychotic medications less than 7 days prior to the pretreatment assessment\n* Patients who do not agree to avoid use of non-pharmacologic treatments, including but not limited to, transcutaneous electrical nerve stimulation unit (TENS), acupuncture, acupressure, and therapeutic massage during the entire study.\n* Patients who do not agree to use additional acetaminophen (up to a maximum total of 3g per day) as the only rescue medication\n* Patients who have received rTMS within the past 6 months","18 Years","65 Years",{"count":83,"type":21},140,[85],"NA","The goal of this clinical trial is to create a machine learning algorithm to improve active repetitive transcranial magnetic stimulation (rTMS) treatments for veterans and\u002For active military personnel by alleviating Gulf War Illness related headaches and body pain (GWI-HAP). This study aims to develop and validate a Support Vector Machine (SVM) model that could replace the trial-and-error process by assessing functional connectivity provided by resting state functional magnetic resonance imaging (rs-fMRI) data to predict the most effective rTMS protocol for each person. All participants will be receiving active rTMS treatment.\n\nThe main questions it intends to answer are:\n\n1. Does the SVM model predict a more effective treatment response rate for predicted respondents undergoing active rTMS at the left dorsolateral prefrontal cortex (DLPFC) compared to predicted non-respondents?\n2. Does the SVM model predict a more effective treatment response rate while undergoing active rTMS at the left dorsolateral prefrontal cortex (DLPFC) and left motor cortex (LMC) in predicted respondents compared to predicted non-respondents?\n\nParticipants will undergo the following:\n\n1. Receive a total of 13 active rTMS treatment sessions over 3-4 months.\n2. Visit the clinic for a total of 15 visits for assessments, check ups, and treatments.\n3. Keep a daily log of their headaches, muscle and joint pain throughout the study.",[25,88,89],"Headache","Muscle and Joint Pain",[91,92,88,93,89],"Repetitive Transcranial Magnetic Stimulation (rTMS)","Support Vector Machine (SVM)","Machine Learning","2026-04-08",{"date":96,"type":34},"2026-04-13",{"date":98,"type":34},"2026-03-25",{"date":100,"type":21},"2029-10",{"name":102,"class":103},"Veterans Medical Research Foundation","OTHER",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":80,"maxAge":81,"enrollmentInfo":110,"targetDuration":4,"studyType":54,"phases":112,"briefSummary":113,"conditions":114,"keywords":117,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":42},"100513962","mechanisms-of-gulf-war-illness-100513962","NCT05972291","Mechanisms of Gulf War Illness","Inclusion Criteria:\n\n1. Veterans 18-65 years old with GWI and chronic GI symptoms (abdominal pain, diarrhea, bloating) that started during their deployment in the Persian Gulf\n2. Veterans 18-65 years old with GWI and chronic GI symptoms (abdominal pain, diarrhea, bloating)\n3. increased intestinal permeability on the lactulose\u002Fmannitol permeability test (ratio \\>0.07)\n4. able and willing to cooperate with the study\n\nExclusion Criteria:\n\n1. current participation in another research protocol or unable to give informed consent\n2. women with a positive urine pregnancy test or breastfeeding\n3. history of inflammatory bowel disease, lactose intolerance and\u002For celiac sprue\n4. \\+ hydrogen breath test for bacterial overgrowth\n5. \\+ anti-endomysial antibody titer\n6. use of NSAIDs 2 weeks before or during the study\n7. known allergy to glutamine or whey protein\n8. abdominal surgery except for removal of gallbladder, uterus, or appendix \\>6 months prior to entry into the study\n9. Abnormal serum BUN and\u002For creatinine\n10. Mannitol recovery out of the normal range of 5-25 U\u002Fg\n11. history of kidney disease\n12. allergies to monosodium glutamate\n13. current use of anti-seizure medications",{"count":111,"type":21},80,[85],"Many veterans with Gulf War Illness developed chronic gastrointestinal symptoms during their deployment to the Persian Gulf. The pathophysiologic mechanisms of these chronic gastrointestinal symptoms are not well understood but cause significant morbidity in veterans. Our proposed studies will provide an innovative and novel treatment trial for chronic gastrointestinal symptoms in veterans with Gulf War Illness that were deployed into war zones. Given that there are currently no specific treatments for these disorders, and that current symptomatic approaches are far from ideal, proof of principle of our trial would be an extremely important advance as it would not only have a beneficial impact on the health of many thousands of our veterans, but also it would substantially reduce the many negative economic effects of this ailment on the VA Health Care System.",[25,115,116],"Irritable Bowel Syndrome","Gastrointestinal Symptoms",[118,119,120],"gastrointestinal","irritable bowel syndrome","glutamine","2025-11-28",{"date":123,"type":34},"2025-12-05",{"date":125,"type":34},"2023-10-16",{"date":127,"type":21},"2027-07-31",{"name":71,"class":72},{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":16,"minAge":137,"maxAge":18,"enrollmentInfo":138,"targetDuration":4,"studyType":54,"phases":140,"briefSummary":141,"conditions":142,"keywords":145,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},"100467475","phase-2-ca-mg-butyrate-in-gwi-100467475","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.","40 Years",{"count":139,"type":21},120,[56],"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.",[25,143,144],"Chronic Fatigue","Neurocognitive Dysfunction",[146,25,147,148,149,135],"SCFA","GWI","Microbiome","Butyric acid","2025-10-29",{"date":152,"type":34},"2025-10-31",{"date":154,"type":34},"2024-01-15",{"date":156,"type":21},"2027-03-31",{"name":71,"class":72},3,{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":15,"sex":16,"minAge":166,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":169,"conditions":170,"keywords":172,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":158},"100495818","validating-gulf-war-illness-blood-biomarkers-100495818","NCT05736146","Validating Gulf War Illness Blood Biomarkers","Validating Blood Biomarkers of Brain Immune and Metabolic Dysfunction in Gulf War Illness","Inclusion Criteria:\n\n1. Age 35 years or older.\n2. For GWI cases, served in the 1990-1991 Gulf War as active duty, national guard, or reserves and meet criteria for the CDC Chronic Multisymptom Illness (CMI) GWI definition or Kansas GWI definition.\n3. For controls, must be a veteran in the same age range as those veterans with GWI as defined above.\n4. Ability to understand written and spoken English or availability of a legal representative who can understand written or spoken English. Participants and caregiver\u002Finformants must be able to read, write and speak the language in which psychometric tests are provided with visual and auditory acuity (corrected) sufficient to allow for accurate testing.\n\nExclusion Criteria:\n\n1. Diagnosed or being treated by a physician for any of the following (Steele et al, 2000) and deemed clinically significant per the discretion of the PI:\n\n   1. Cancer (except for non-melanoma skin cancers)\n   2. Chronic infectious disease\n   3. Problems resulting from postwar injuries.\n   4. Liver disease\n   5. Lupus\n   6. Multiple sclerosis\n   7. Stroke\n   8. Serious psychiatric condition (those associated with psychosis and\u002For for which the respondent had been hospitalized since 1991).\n   9. Dementia or any type of Parkinson's disease (PD).\n2. Hospitalized in the last 5 years for alcohol or drug dependence, depression, or post-traumatic stress disorder (PTSD).\n3. Female subject is either pregnant or nursing.","35 Years",{"count":168,"type":21},100,"The investigators goals are to identify blood lipids\u002Fmetabolites that correlate with cognitive decline in the presence of the APOE ε4 allele among veterans with GWI. To determine the effect of dietary, medical and biological factors that influence lipid and metabolites in blood from GW veterans. To identify blood lipid\u002Fmetabolite profiles that correlate with bioenergetics deficits and glial activation in the brains of GWI. To validate blood biomarker signatures of GWI using APOE genotyping and blood lipids\u002Fmetabolites that correlate with the CNS dysfunction in GWI.",[171,25],"Gulf War Syndrome",[173,174],"Gulf War","APOE","2025-07-21",{"date":177,"type":34},"2025-07-24",{"date":179,"type":34},"2022-06-30",{"date":181,"type":21},"2026-03-01",{"name":183,"class":103},"Roskamp Institute Inc.",{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":16,"minAge":191,"maxAge":18,"enrollmentInfo":192,"targetDuration":4,"studyType":54,"phases":193,"briefSummary":194,"conditions":195,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":196,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":202},"100457951","nicotinamide-riboside-clinical-trial-for-gwi-100457951","NCT05243290","Nicotinamide Riboside Clinical Trial for GWI","A Randomized Double-blind Placebo-controlled Clinical Trial of Nicotinamide Riboside for Restoring Mitochondrial Bioenergetics in Gulf War Illness","Inclusion Criteria:\n\n* Both sexes, all ethnic groups, and ages 47 to 70 years.\n* Subject willing and able to give informed consent.\n* Medically stable as per the investigator's discretion.\n* Negative urine pregnancy test for females of childbearing potential. A woman is considered of childbearing potential unless she is surgically sterile (hysterectomy or tubal ligation) or is postmenopausal (no menstrual cycle for 2 years or more).\n* If female of childbearing potential, must be willing to use adequate birth control during the study and for 30 days after the last dose. Females agreeing to take an acceptable form of birth control per investigator discretion (where relevant). Females must prevent pregnancy or otherwise be unable to conceive.\n* Veterans deployed to the Gulf War between August 1990 and August 1991.\n* Veteran meets criteria for the CDC Chronic Multisymptom Illness (CMI) GWI definition or Kansas GWI definition.\n* Weight of 50.0kg - 200.0kg (110 lbs. - 440 lbs.).\n\nExclusion Criteria:\n\n* Diagnosed by a physician with medical or psychiatric conditions that would account for their symptoms or interfere with their ability to report their symptoms, as per investigator discretion.\n* Female subject is either pregnant or nursing; or if female subject is of childbearing age is not currently on or is unwilling and\u002For unable to use birth control.\n* Have contraindications, allergy, or sensitivity to NR, vitamin B3, or excipients (microcrystalline cellulose, silicon dioxide, magnesium stearate, hypromellose, and\u002For titanium dioxide).\n* Any significant medical condition that could interfere with study conduct, as per investigator discretion. These may include but are not limited to the following: untreated chronic hypertension (defined as systolic \\> 180 mmHg; diastolic \\>110 mmHg), myocardial infarction within 6 months of screening, renal failure, hepatic failure, and\u002For receiving chemotherapy.\n* Clinically significant lab values for clinical laboratory assessments, as per investigator discretion.\n* Poor venous access.\n* Current use of any NR supplement products (such as nicotinamide, nicotinamide mononucleotide (NMN), vitamin B3\u002FNiacin, vitamin B complex, etc.) within 30 days of screening.\n* Participation in another clinical trial involving dietary or pharmaceutical intervention within 90 days of screening.","47 Years",{"count":53,"type":21},[85],"In this multi-site trial, we will use a randomized, double-blind, placebo-controlled study design to test whether 300 mg of Nicotinamide Riboside (NR) can achieve the primary objective of increasing plasma NAD+ levels in participants with Gulf War Illness (GWI).",[25],{"date":177,"type":34},{"date":198,"type":34},"2022-04-13",{"date":200,"type":21},"2025-12-31",{"name":183,"class":103},2,{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":16,"minAge":210,"maxAge":211,"enrollmentInfo":212,"targetDuration":4,"studyType":54,"phases":214,"briefSummary":215,"conditions":216,"keywords":217,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":42},"100433685","phase-2-study-of-bacopa-in-gulf-war-illness-patients-100433685","NCT04927338","Study of Bacopa in Gulf War Illness Patients","Phase II, Placebo-controlled Study of BacoMind® Bacopa Monnieri Standardized Extract in Gulf War Illness","Inclusion Criteria:\n\n1. Born in years 1942 to1978\n2. Served in the Gulf War theater for any period between August 1990 and July 1991\n3. Meets modified Kansas case definition criteria and CDC case definition for Gulf War Illness (GWI). The modified Kansas definition, which includes the CDC criteria includes:\n\n   1. Allowance for normal illnesses of aging, such as hypertension and diabetes if the conditions are treated and are in demonstrable stable and normal ranges at the time of screening and assessment.\n   2. Allowance of stable comorbid conditions such as post-traumatic stress disorder (PTSD), major depressive disorder (MDD), and traumatic brain injury (TBI) that have not required hospitalization in the 5 years prior to recruitment. Severe TBI is excluded.\n4. Able to consent to the study\n5. Participants of childbearing potential must practice effective contraception during the study so that, in the opinion of the Investigator, they will be compliant with birth control measures during the study.\n6. Agrees to participate in follow-up visits.\n\nExclusion Criteria:\n\n1. They are scheduled for a surgery during the period of study participation, had minor surgery within 3 months prior to screening, or had major surgery within 6 months prior to screening,\n2. Self-report of current untreated major depression with psychotic or melancholic features (as determined by self-report), schizophrenia, bipolar disorder, delusional disorders, dementias of any type, or substance abuse during the last two years (excluding cannabis products),\n3. Any serious allergic disease (self-report), possibly resulting in anaphylaxis, such as food\u002Fdrug allergies, including allergic asthma, or allergy to any ingredient of the active product or placebo, including allergies to FD\\&C Yellow No. 5 (tartrazine),\n4. Renal disease (self-report; laboratory results: renal insufficiency with serum creatinine \\> 2.0 mg\u002FdL or eGFR \\\u003C 44; or currently on renal dialysis),\n5. Hepatic insufficiency (bilirubin \\>2.5mg\u002FdL or transaminases \\>3x the upper limit of normal (ULN)). Participants with Gilberts syndrome are eligible for the study if other liver function tests are normal, regardless of bilirubin level,\n6. Pregnancy (premenopausal female participants),\n7. Current heavy alcohol or tobacco use (self-report). Heavy use is defined as alcohol consumption not to exceed approximately 15 drinks per week (with a drink defined as 12 oz beer, 5 oz wine, or 1.5 oz distilled spirits) and tobacco use not to exceed 20 cigarettes (or equivalent) per day.\n8. Current exclusionary diagnosis that could reasonably explain the symptoms of their fatiguing illness and their severity, using the exclusion criteria best described in the Ambiguities in case definition paper for Chronic Fatigue Syndrome (CFS), as described in detail in Reeves et al., 2003, which clarifies exclusionary conditions. Specifically, the exclusionary diagnoses that are not otherwise listed above comprise:\n\n   * organ failure (e.g., emphysema, cirrhosis, cardiac failure, chronic renal failure)\n   * chronic infections (e.g., AIDS, hepatitis B or C) or inflammatory bowel disease (IBD) (via self report)\n   * major neurologic diseases that could cause fatigue or neurologic deficits such as (e.g., epilepsy, stroke, brain tumor, multiple sclerosis, Parkinson's Disease, Alzheimer's disease) or history of CNS demyelinating disease (e.g., multiple sclerosis, neuromyelitis optica spectrum disorder) (Self report),\n   * cancer or cancer treatment (e.g., chemotherapy, radiation of brain), or current use of biologic modifiers that could affect immune function (e.g., Etanercept, Rituximab) (self-report)\n   * untreated primary sleep disorders (e.g., sleep apnea, narcolepsy)\n   * uncontrolled diabetes (HgbA1c \\> 7)\n9. Temporary conditions discovered at screening for which participants may be rescreened 6 weeks after resolution of condition.\n\n   * Temporary effects of medications\n   * Temporary sleep deprivation\n   * Untreated hypothyroidism\u002Fhyperthyroidism, hypothyroidism\u002Fhyperthyroidism that has been inadequately controlled during the last 3 months, or free T4 level not within normal limit\n   * Active infection\n10. Participating in another interventional clinical trial of an investigational therapy (including social-behavioral therapy) within 6 weeks prior to consent to participate in this study, or planning to participate in another interventional clinical trial of an investigational therapy during this study,\n11. Use of Bacopa within 6 weeks prior to the enrollment in this study,\n12. Diagnosed bleeding disorder or current use of anticoagulants and\u002For antiplatelets, except for low dose nonsteroidal anti-inflammatories (NSAIDS).","46 Years","78 Years",{"count":213,"type":21},170,[56],"Gulf War Illness is a condition that affects multiple major organ systems, resulting in a diverse array of symptoms that include debilitating fatigue, memory and cognition difficulties, headaches, sleep disturbances, gastrointestinal problems, skin rashes, and musculoskeletal\u002Fjoint pain. This phase II, double masked, randomized, placebo-controlled, two-arm study will evaluate cognitive function as evidence of efficacy of the nutraceutical intervention, Bacopa, on central nervous system symptom management of Gulf War Illness, along with assessments of safety of the intervention.",[25],[61,25,218],"Nutraceutical","2025-07-02",{"date":221,"type":34},"2025-07-04",{"date":223,"type":34},"2022-12-01",{"date":225,"type":21},"2026-04",{"name":227,"class":103},"Nova Southeastern University",{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":234,"enrollmentInfo":235,"targetDuration":4,"studyType":54,"phases":237,"briefSummary":239,"conditions":240,"keywords":241,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":158},"100491188","phase-3-confirmation-of-diet-as-a-treatment-for-gulf-war-illness-100491188","NCT05675878","Confirmation of Diet as a Treatment for Gulf War Illness","Inclusion Criteria:\n\n* Males and Females of all races and ethnicities who are ≤75 yrs of age\n* Served in the 1990-1991 Persian Gulf War\n* Fulfill both Center for Disease Control (CDC) and Kansas definitions of Gulf War Illness\n* Stable medication regimen for ≥1 month and willing to keep medications and supplements stable throughout study participation\n\nExclusion Criteria:\n\n* Recent substance use disorder (past year)\n* Unwilling to stop using alcohol, tobacco (including vaping) and\u002For marijuana; or unwilling to change diet\n* Diagnosed seizure disorder or severe asthma requiring past hospitalization\n* Currently taking medication which affects glutamatergic or GABAergic neurotransmission (but can work with their physician to wean off of these medications prior to participating)","75 Years",{"count":236,"type":21},160,[238],"PHASE3","This clinical trial aims to confirm previous findings from a smaller study which demonstrated significant improvements in all symptoms among veterans with Gulf War Illness after one month on the dietary intervention. The main objectives of this study are: 1) to confirm previous findings of treatment response to the diet in a larger and more diverse group; 2) to examine how changes in the nervous system may be the reason for improvement; and 3) to identify markers which change in the blood after one month on the diet. Participants will have baseline measures collected and then will be randomized into the intervention or wait-listed control group, which they will follow for one month before being reassessed.",[171,25],[25,147,171,242,243],"Diet","Treatment","2024-07-05",{"date":246,"type":34},"2024-07-09",{"date":248,"type":34},"2023-03-01",{"date":250,"type":21},"2025-12-30",{"name":252,"class":103},"American University"]