[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551926":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":29,"responsibleParty":47,"collaborators":19,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":19,"eligibilityCriteria":54,"healthyVolunteers":51,"sex":55,"minAge":56,"maxAge":19,"enrollmentInfo":57,"targetDuration":19,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":19,"overallStatus":32,"whyStopped":19,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Prebiotic food-enriched diet (PreFED)","EXPERIMENTAL","Participants will receive prebiotic food-enriched snacks and supportive nutritional counseling to increase prebiotic foods in the diet.",[13],"Other: Prebiotic Food-Enriched Diet",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"Prebiotic Food-Enriched Diet","Given by PO",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Erez Baruch, MD,PHD","PRINCIPAL_INVESTIGATOR",[25],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},"CONTACT","713-745-5530","ENBaruch@mdanderson.org,",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"MD Anderson Cancer Center","RECRUITING","Houston","Texas","77030","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-95.36327,29.76328,{"lat":42,"lon":41},[45,46],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},{"name":22,"role":23,"phone":19,"phoneExt":19,"email":19},{"type":48,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100551926","phase-2-prebiotic-food-enriched-diet-prefed-to-enhance-the-microbiome-and-response-to-first-line-immunotherapy-in-unresectable-melanoma-100551926",false,"NCT06466434","Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma","Inclusion Criteria:\n\n* Age ≥18 years old\n* English-speaking\n* Body mass index (BMI) 18.5-45 kg\u002Fm2\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Histologically confirmed stage III\u002FIV, unresectable cutaneous, uveal, acral or mucosal melanoma. Asymptomatic brain metastases are allowed.\n* Planned initiation of 1st line standard-of-care approved immune checkpoint blockade (anti-PD1 +\u002F- anti-CTLA4 or anti-LAG3 inhibitors or talimogene laherparepvec T-VEC) in the metastatic setting. Prior targeted therapy or ICB in the adjuvant setting is allowed.\n* Returning to MD Anderson for restaging and follow-up (ICB treatment may occur locally)\n* Measurable disease per RECIST 1.1 or RANO criteria. Up to 10 patients without measurable can be enrolled.\n* WOCP must have negative UPT within 1 week of beginning dietary intervention.\n* Self-reported willingness to eat the provided foods (with some tailoring to their food preferences)\n* Self-reported willingness to comply with scheduled visits, undergo venipuncture, provide stool samples.\n\nExclusion Criteria:\n\n* Previous ICB treatment in the metastatic setting\n* History of inflammatory bowel disease, total colectomy, or bariatric surgery.\n* Currently taking steroids \\> Prednisone 10 mg\u002Fday or equivalent\n* Medical contraindications to the Intervention Diet as determined by the treating physician.\n* Self-reported major dietary restrictions, including but not limited to relevant food allergies, celiac disease, or diets such as vegan, ketogenic, extended fasting.\n* Insulin-dependent diabetes or condition requiring bile acid sequestrants\n* Unable or unwilling to undergo study procedures.\n* IV antibiotic use in the past month or oral antibiotic use in past 2 weeks.\n* Regularly taking supplements containing prebiotics, fiber and\u002For probiotics, and unable\u002Funwilling to discontinue for the purpose of the study.\n* Current smoker or heavy drinker (defined as \\>14 drinks per week) or current illicit drug use.\n* Currently pregnant, planning to become pregnant, or lactating.\n* Concurrent malignancy requiring systemic therapy other than hormonal therapy.\n* Cognitively impaired adults","ALL","18 Years",{"count":58,"type":59},75,"ESTIMATED","INTERVENTIONAL",[62],"PHASE2","To learn about the possible effects of a prebiotic food-enriched diet (PreFED) targeting the gut microbiome in participants with melanoma who are starting immune checkpoint blockade (ICB) therapy.",[65],"Unresectable Melanoma","2026-03-23",{"date":68,"type":69},"2026-03-24","ACTUAL",{"date":71,"type":69},"2024-09-01",{"date":73,"type":59},"2029-06-30",{"name":5,"class":6},1]