[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635664":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":59,"collaborators":18,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":18,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":18,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":88,"whyStopped":18,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"TC Erciyes University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Mediterranean Diet Intervention Group","EXPERIMENTAL","Participants receive personalized Mediterranean Diet counseling from a dietitian at Erciyes University Children's Hospital over 12 weeks. Face-to-face sessions occur at weeks 1, 6, and 12, with phone or video follow-ups during other weeks. No food is provided; the focus is on modifying existing dietary habits. The intervention aims to improve adherence to the Mediterranean Diet, increase polyphenol intake, reduce dietary inflammatory index, and limit ultra-processed foods.",[13],"Behavioral: Mediterranean Diet-Based Individual Nutrition Counseling",{"label":15,"type":16,"description":17,"interventionNames":18},"Healthy Household Control Group","NO_INTERVENTION","Participants in the control group receive standard dietary advice and routine care without personalized Mediterranean Diet counseling. No specific intervention is provided, and participants continue their usual dietary habits. Follow-up occurs over 12 weeks.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Mediterranean Diet-Based Individual Nutrition Counseling","Participants receive individualized nutrition counseling from a dietitian at Erciyes University Children Hospital, tailored to each participant. The program aims to improve adherence to the Mediterranean Diet, increase polyphenol intake, reduce the dietary inflammatory index(DII), and limit ultra-processed foods. Diet is assessed via 3-day food records and KIDMED(Mediterranean Diet Quality Index for children and adolescents) scores. Guidance is provided to improve dietary mistakes and increase physical activity(IPAQ, International Physical Activity Questionnaire). Weekly follow-ups monitor adherence. Additional assessments include stool samples, anthropometrics, PSQI (Pittsburgh Sleep Quality Index), CHAQ(Childhood Health Assessment Questionnaire), SLEDAI-2K(Systemic Lupus Erythematosus Disease Activity Index 2000), and SLICC\u002FSDI(Systemic Lupus International Collaborating Clinics\u002FAmerican College of Rheumatology Damage Index). No food is provided; focus is on modifying existing habits.",[9],[26],{"name":27,"affiliation":28,"role":29},"ZEYNEP CAFEROGLU AKIN, PhD","Erciyes University, Faculty of Health Sciences, Department of Nutrition and Dietetics","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"SABRIYE BALLI, MSc (PhD Candidate)","CONTACT","0090-534-884-0893","sabriyeballi@hotmail.com",{"name":27,"role":33,"phone":37,"phoneExt":38,"email":39},"0090-352-437-9282","28651","zcaferoglu@erciyes.edu.tr",[41],{"facility":42,"status":18,"city":43,"state":44,"zip":45,"country":46,"countryCode":18,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Erciyes University Mustafa Eraslan and Fevzi Mercan Children's Hospital","Kayseri","Melikgazi","38039","Turkey (Türkiye)",{"type":48,"coordinates":49},"Point",[50,51],35.48528,38.73222,{"lat":51,"lon":50},[54],{"name":55,"role":33,"phone":56,"phoneExt":57,"email":58},"AYSENUR PAC KISAARSLAN, MD","0090-352-207-6666","25476","apkisaarslan@erciyes.edu.tr",{"type":29,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Sabriye BALLI","Principal Investigator","100635664","mediterranean-diet-and-gut-microbiota-in-children-with-systemic-lupus-erythematosus-100635664",false,"NCT07555626","Mediterranean Diet and Gut Microbiota in Children With Systemic Lupus Erythematosus","Effects of a Mediterranean Diet-Based Nutritional Intervention on Gut Microbiota, Disease Activity, and Nutritional Status in Children With Systemic Lupus Erythematosus","Inclusion Criteria:\n\nFor participants with Systemic Lupus Erythematosus (SLE):\n\n* Diagnosis of SLE according to the SLICC classification criteria.\n* SLE diagnosis established at least 6 months prior to enrollment.\n\nFor healthy controls (household members):\n\n* Living in the same household as participants with SLE.\n* Body mass index (BMI) within the normal range.\n\nExclusion Criteria:\n\nFor participants with SLE:\n\n* Presence of active infection.\n* Renal failure, or history of major trauma or surgery within the past 6 months.\n* Presence of additional chronic diseases other than SLE.\n* Use of antibiotics or probiotics within the past 4 weeks.\n* Following a specific or restrictive diet.\n* Illiteracy or cognitive impairment that may limit understanding of the intervention.\n\nFor healthy controls (household members):\n\n* Presence of active infection\n* Presence of any chronic disease\n* Use of antibiotics or probiotics within the past 4 weeks\n* Following a specific or restrictive diet\n* Illiteracy or cognitive impairment that may limit understanding of study procedures",true,"ALL","8 Years","18 Years",{"count":74,"type":75},60,"ESTIMATED","INTERVENTIONAL",[78],"NA","The goal of this clinical trial is to learn if a Mediterranean diet can improve gut microbiota, disease activity, and nutrition in children with systemic lupus erythematosus (SLE). The study will include children with SLE and healthy family members living in the same home.\n\nThe main questions it aims to answer are:\n\nDoes a Mediterranean diet improve gut microbiota in children with SLE? Does the diet help reduce disease activity? Does the diet improve overall nutrition? Researchers will compare children with SLE to healthy family members to better understand how diet, gut microbiota, and health are related.\n\nParticipants will:\n\nGive stool samples at the beginning and end of the study to analyze gut microbiota.\n\nHave body measurements taken. Record what they eat for 3 days (2 weekdays and 1 weekend day). Answer questions about their diet, physical activity, sleep, and health. Children with SLE in the intervention group will receive nutrition counseling based on the Mediterranean diet for 12 weeks. The counseling will focus on increasing foods rich in polyphenols and reducing processed foods to improve overall diet quality. They will also receive advice on physical activity.\n\nAt the end of the study, some participants will join a group discussion to share their experiences.",[81],"Systemic Lupus Erythematosus (SLE)",[83,84,85,86,87],"Mediterranean Diet","Systemic Lupus Erythematosus","Gut microbiota","Individual nutrition counseling","Child","NOT_YET_RECRUITING","2026-04-21",{"date":91,"type":92},"2026-04-29","ACTUAL",{"date":94,"type":75},"2026-06",{"date":96,"type":75},"2029-02",{"name":5,"class":6},1]