[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639818":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":40,"centralContacts":44,"locations":45,"responsibleParty":65,"collaborators":67,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":44,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":44,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":44,"overallStatus":93,"whyStopped":44,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"City of Hope Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Supportive care (mPB)","EXPERIMENTAL","Participants receive microencapsulated sodium propionate PO QID for 1 week. Participants then receive microencapsulated sodium propionate PO QID and microencapsulated sodium butyrate PO QID for 1 week. Participants also undergo collection of blood samples throughout the study.",[13,14,15],"Procedure: Biospecimen Collection","Drug: Microencapsulated Sodium Butyrate","Drug: Microencapsulated Sodium Propionate",[17,27,35],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"PROCEDURE","Biospecimen Collection","Undergo collection of blood samples",[9],[23,24,25,26],"Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen Collection",{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Microencapsulated Sodium Butyrate","Given PO",[9],[33,34],"Microencapsulated Formulation-containing Sodium Butyrate","MSB",{"type":28,"name":36,"description":30,"armGroupLabels":37,"otherNames":38},"Microencapsulated Sodium Propionate",[9],[39],"Microencapsulated Formulation-containing Sodium Propionate",[41],{"name":42,"affiliation":5,"role":43},"Karamjeet S Sandhu","PRINCIPAL_INVESTIGATOR",null,[46],{"facility":5,"status":44,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Duarte","California","91010","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-117.97729,34.13945,{"lat":56,"lon":55},[59,64],{"name":60,"role":61,"phone":62,"phoneExt":44,"email":63},"Karamjeet S. Sandhu","CONTACT","626-218-2405","ksandhu@coh.org",{"name":60,"role":43,"phone":44,"phoneExt":44,"email":44},{"type":66,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR",[68],{"name":69,"class":70},"National Cancer Institute (NCI)","NIH","100639818","phase-1-evaluating-the-effects-of-propionate-and-butyrate-supplementation-on-the-intestinal-health-of-healthy-volunteers-100639818",false,"NCT07611370","Evaluating the Effects of Propionate and Butyrate Supplementation on the Intestinal Health of Healthy Volunteers","A Pilot Feasibility Study of Oral Administration of Microencapsulated Propionate and Butyrate in Healthy Volunteers","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n* Age: ≥ 18 years and ≤ 75 years old\n* Ability to read and understand and willingness to sign a written informed consent\n* Ability to understand English to fill out required forms (e.g. Pill Diary and Symptom Diary)\n* Participants are not taking butyrate or propionate as supplement(s)\n\n  * Those who are already taking butyrate or propionate as supplement(s) are allowed only if they are willing to stop the supplement(s) ≥ 7 days prior to baseline samples and for the duration of this study\n\nExclusion Criteria:\n\n* History of migraines and chronic gastrointestinal diseases, such as inflammatory bowel disease or Crohn's disease\n* History of allergic reactions to compounds of similar chemical or biologic composition to study agent\n* Females only: Pregnant, breastfeeding, or planning to get pregnant\n* Antibiotic exposure within 2 weeks prior to day 1 of study",true,"ALL","18 Years","75 Years",{"count":83,"type":84},12,"ESTIMATED","INTERVENTIONAL",[87],"PHASE1","This clinical trial evaluates how propionate and butyrate supplementation alters intestinal health in healthy volunteers and whether it would be feasible to administer these supplements to patients undergoing allogeneic hematopoietic stem cell transplant in the future. Propionate and butyrate are short chain fatty acids naturally produced in the intestines during the fermentation of dietary fibers. Greater levels of propionate and butyrate may improve intestinal barrier function, and propionate specifically has been shown to modulate immunity, energy metabolism, and gut-brain communication. The protective effects of propionate and butyrate supplementation on intestinal health may be especially beneficial for patients undergoing donor stem cell transplant, as these patients can experience significant gastrointestinal injury during treatment. The results of this study may help researchers determine whether propionate and butyrate supplementation positively alters the gut microbiome and whether or not supplementation could be used in the future for patients undergoing a donor stem cell transplant.",[90,91,92],"Graft Versus Host Disease","Hematopoietic and Lymphatic System Neoplasm","Malignant Solid Neoplasm","NOT_YET_RECRUITING","2026-05-20",{"date":96,"type":97},"2026-05-28","ACTUAL",{"date":99,"type":84},"2026-09-30",{"date":101,"type":84},"2027-06-30",{"name":5,"class":6},1]