[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550551":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":18,"centralContacts":22,"locations":28,"responsibleParty":47,"collaborators":49,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":10,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":61,"maxAge":10,"enrollmentInfo":62,"targetDuration":10,"studyType":65,"phases":10,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":30,"whyStopped":10,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"University of Central Florida","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"Control",null,"Patients who are not diagnosed with HD",{"label":13,"type":10,"description":14,"interventionNames":10},"Experimental Group 1","Underweight HD patients",{"label":16,"type":10,"description":17,"interventionNames":10},"Experimental Group 2","Overweight HD patients",[19],{"name":20,"affiliation":5,"role":21},"Amber Southwell, PhD","PRINCIPAL_INVESTIGATOR",[23],{"name":24,"role":25,"phone":26,"phoneExt":10,"email":27},"Amoy Fraser, PhD, CCRP, PMP","CONTACT","4072668742","amoy.fraser@ucf.edu",[29],{"facility":5,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"RECRUITING","Orlando","Florida","32816","United States","US",{"type":37,"coordinates":38},"Point",[39,40],-81.37924,28.53834,{"lat":40,"lon":39},[43,44],{"name":24,"role":25,"phone":26,"phoneExt":10,"email":27},{"name":45,"role":25,"phone":26,"phoneExt":10,"email":46},"Erica Martin, BS","erica.martin@ucf.edu",{"type":48,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[50],{"name":51,"class":6},"University of South Florida","100550551","gut-microbiomes-in-hd-100550551",false,"NCT06448546","Gut Microbiomes in HD","Investigating the Role of the Gut Microbiome in Huntington's Disease","* Inclusion Criteria:\n\n  * 18 years or older\n  * Provide informed consent\n  * Able to read and speak English\n  * Agree to comply with study procedures\n* Inclusion criteria for the control group include:\n\n  * CAG repeat length ≤ 26.\n  * BMI 18.5-24.9\n* Inclusion criteria for experimental group 1 include:\n\n  * BMI \\\u003C 18.5 (underweight) or significant, involuntary weight loss within the past 12 months.\n  * CAG repeat length 40 - 59.\n  * Documentation of the Clinical Diagnosis of HD with a high level of certainty (\\>99% confidence) using the validated Unified Huntington's Disease Rating Scale (UHDRS).\n  * Stage I-III on the Functional Assessment component of the UHDRS\n* Inclusion criteria for experimental group 2 include:\n\n  * BMI \\> 25.0 (overweight - obesity) or BMI ≤ 25.0 with significant, unexplained weight gain within the past 12 months\n  * CAG repeat length 40 - 59.\n  * Documentation of the Clinical Diagnosis of HD with a high level of certainty (\\>99% confidence) using the validated UHDRS.\n  * Stage I-III on the Functional Assessment component of the UHDRS\n* Exclusion Criteria:\n\n  * CAG repeat length ≥ 60 to exclude participants with juvenile onset HD.\n  * CAG repeat length 36 - 39 to exclude participants with reduced penetrance. As this is a pilot study, we are primarily interested in participants with typical HD characteristics.\n  * UHDRS Functional Capacity stage ≥ 4 to exclude late-stage HD patients who may be institutionalized and receive nutrition through a feeding tube.\n  * Use of any of the following drugs within the last 6 months:\n\n    * System antibiotics, antifungals, antivirals, or anti-parasitics (intravenous, intramuscular, or oral)\n    * Corticosteroids (intravenous, intramuscular, oral, nasal, or inhaled)\n    * Cytokines\n    * Methotrexate, immunosuppressive cytotoxic agents, or chemotherapy\n    * Commercial probiotics ≥ 100 million CFU (fermented foods, yogurts, and other homeopathic probiotics and prebiotics do not apply)\n  * Use of topical antibiotics or topical steroids within the last 7 days\n  * History of active, uncontrolled gastrointestinal disorders or diseases, including:\n\n    * Inflammatory bowel disease\n    * Ulcerative colitis\n    * Crohn's disease\n    * Irritable bowel syndrome\n    * Infectious gastroenteritis, colitis, or gastritis\n    * Clostridium difficile or Helicobacter pylori infection\n    * Persistent or chronic constipation or diarrhea\n  * Acute illness with or without fever at time of sample collection\n  * Positive for HIV, hepatitis B, or hepatitis C\n  * Confirmed or suspected immunodeficient condition\u002Fstate\n  * Major surgery of the GI tract, excluding cholecystectomy and appendectomy\n  * Unstable dietary history within the past month, such as elimination or significant increase of a major food group in the diet\n  * Recent history of chronic, excessive alcohol consumption\n  * Travel outside of the United States within the last 3 months",true,"ALL","18 Years",{"count":63,"type":64},36,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to find out if there is a connection between the naturally occurring bacteria in our bodies and the progression of Huntington disease. The investigators are trying to determine if patients who are diagnosed with adult-onset HD and who exhibit a rapid rate of disease progression have unique populations of bacteria in their gut as compared to patients with slower progression.",[68],"Huntington Disease",[68,70,71],"HD","Gut Microbiome","2025-06-15",{"date":74,"type":75},"2025-06-18","ACTUAL",{"date":77,"type":64},"2025-06",{"date":79,"type":64},"2029-06",{"name":5,"class":6},1]