[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07713940":3,"trial-entities:NCT07713940":105,"trial-summary:NCT07713940":109},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":39,"secondary_outcomes":47,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":14,"eligibility_criteria":54,"std_ages":65,"locations":68,"central_contacts":87,"overall_officials":90,"references":93,"see_also_links":104},"NCT07713940","161474_3","Effect of Anti-inflammatory Diet in Systemic Lupus Erythematous","RECRUITING","2029-07-01","2026-07","2026-07-20","2026-07-01","University of California, San Diego","OTHER",false,"To study the effect of anti-inflammatory diet on clinical and biological outcomes in lupus","The investigators aim to evaluate how inflammation changes in individuals with lupus and to identify molecules and gut bacteria that may help predict disease flares. Blood and stool samples will be analyzed in the laboratory and compared with samples collected from the same participants following dietary changes.\n\nThis is an exploratory study designed to generate preliminary data on the short-term effects of dietary changes and treatment on blood biomarkers and the gut microbiome. The findings may provide insights into the mechanisms underlying lupus and could ultimately contribute to the development of new therapeutic approaches.",[18],"Systemic Lupus Erthematosus (SLE)",[20,21,22,23,24,25,26],"lupus","diet","anti-inflammatory diet","mediterranean diet","cellcept","mycophenalate","microbiome","INTERVENTIONAL","TREATMENT",[30],"NA",{"count":32,"type":33},36,"ESTIMATED",[35],{"type":36,"name":22,"description":37,"armGroupLabels":38},"DIETARY_SUPPLEMENT","anti-inflammatory diet for 6 weeks",[22],[40,44],{"measure":41,"description":42,"timeFrame":43},"PROMIS pain interference","PROMIS Pain Interference: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference. Scores are typically reported as T-scores ranging from approximately 20 to 80 (theoretical range varies by item bank). Higher scores indicate worse outcomes, reflecting greater pain interference with daily activities.","6 weeks",{"measure":45,"description":46,"timeFrame":43},"PROMIS fatigue","PROMIS Fatigue: Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue. Scores are typically reported as T-scores ranging from approximately 20 to 80. Higher scores indicate worse outcomes, reflecting greater fatigue.",[48],{"measure":49,"description":50,"timeFrame":43},"PROMIS physical function","PROMIS Physical Function: Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function. Scores are typically reported as T-scores ranging from approximately 20 to 80. Higher scores indicate better outcomes, reflecting better physical functioning.","ALL","18 Years",null,{"inclusion":55,"exclusion":59,"raw_text":64},[56,57,58],"patients who meet the 2019 EULAR\u002FACR Classification Criteria for SLE","patients who are on Cellcept or Myfortic for at least 3 months prior to screening","patients with a score of ≥55 on the Patient Reported Outcomes Measurement Information System (PROMIS) Pain interference scale.",[60,61,62,63],"pregnant or lactating patients,","patients with food allergy","patients on antibiotics within 4 weeks of the screening","patients that change the SLE therapy during the length of the study (12 weeks).","Inclusion Criteria:\n\n* patients who meet the 2019 EULAR\u002FACR Classification Criteria for SLE\n* patients who are on Cellcept or Myfortic for at least 3 months prior to screening\n* patients with a score of ≥55 on the Patient Reported Outcomes Measurement Information System (PROMIS) Pain interference scale.\n\nExclusion Criteria:\n\n* pregnant or lactating patients,\n* patients with food allergy\n* patients on antibiotics within 4 weeks of the screening\n* patients that change the SLE therapy during the length of the study (12 weeks).",[66,67],"ADULT","OLDER_ADULT",[69],{"facility":70,"status":7,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":84},"Altman Clinical Translational Research Insitute (UC San Diego)","La Jolla","California","92097","United States",[76,81],{"name":77,"role":78,"phone":79,"email":80},"Monica Guma, MD, PhD","CONTACT","858-","mguma@health.ucsd.edu",{"name":82,"role":83},"Monica Guma, MD.PhD","PRINCIPAL_INVESTIGATOR",{"lat":85,"lon":86},32.84727,-117.2742,[88],{"name":77,"role":78,"phone":89,"email":80},"858-822-6523",[91],{"name":77,"affiliation":92,"role":83},"UC San Diego",[94,98,101],{"pmid":95,"type":96,"citation":97},"32025586","BACKGROUND","Bustamante MF, Agustin-Perez M, Cedola F, Coras R, Narasimhan R, Golshan S, Guma M. Design of an anti-inflammatory diet (ITIS diet) for patients with rheumatoid arthritis. Contemp Clin Trials Commun. 2020 Jan 21;17:100524. doi: 10.1016\u002Fj.conctc.2020.100524. eCollection 2020 Mar.",{"pmid":99,"type":96,"citation":100},"35802808","Coras R, Martino C, Gauglitz JM, Cedola F, Tripathi A, Jarmusch AK, Alharthi M, Fernandez-Bustamante M, Agustin-Perez M, Singh A, Choi SI, Rivera T, Nguyen K, Shekhtman T, Holt T, Lee S, Golshan S, Dorrestein PC, Knight R, Guma M. Baseline microbiome and metabolome are associated with response to ITIS diet in an exploratory trial in patients with rheumatoid arthritis. Clin Transl Med. 2022 Jul;12(7):e959. doi: 10.1002\u002Fctm2.959. No abstract available.",{"pmid":102,"type":96,"citation":103},"40944120","Sala-Climent M, Bu K, Coras R, Cedeno M, Zuffa S, Murillo-Saich J, Mannochio-Russo H, Allaband C, Hose MK, Quan A, Choi SI, Nguyen K, Golshan S, Blank RB, Holt T, Lane NE, Knight R, Scher J, Dorrestein P, Clemente J, Guma M. Targeted Microbial Shifts and Metabolite Profiles Were Associated with Clinical Response to an Anti-Inflammatory Diet in Osteoarthritis. Nutrients. 2025 Aug 22;17(17):2729. doi: 10.3390\u002Fnu17172729.",[],{"nct_id":4,"conditions":106,"biomarkers":108},[107],"Systemic Lupus Erythematosus",[],{"nct_id":4,"found":110,"summary":111,"prompt_version":121},true,{"design":112,"status":113,"heading":114,"summary":115,"follow_up":116,"word_count":117,"commitments":118,"compensation":119,"drugs_mentioned":120},"This is an interventional study with a planned enrollment of 36 participants. It is designed to explore the short-term effects of dietary changes.","completed","Anti-inflammatory Diet for Systemic Lupus Erythematosus (SLE)","This study is looking at how an anti-inflammatory diet affects people with Systemic Lupus Erythematosus (SLE), an autoimmune disease. Researchers want to see if this diet can help reduce pain and fatigue. You might be able to join if you are an adult with SLE, meet specific classification criteria, are currently taking Cellcept or Myfortic for at least three months, and have a certain level of pain interference. The study will measure changes in your pain and fatigue levels after six weeks on the diet. The goal is to understand how diet might impact lupus and potentially lead to new ways to help manage the condition. The current recruitment status is unclear.","The primary outcomes are measured at 6 weeks after starting the diet.",112,"Participants will follow an anti-inflammatory diet for 6 weeks. Blood and stool samples will be collected and analyzed.","Not stated in the trial record.",[22],"v2"]