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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.
The main questions it aims to answer are:
Does 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.
Participants will:
Give stool samples at the beginning and end of the study to analyze gut microbiota.
Have 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.
At the end of the study, some participants will join a group discussion to share their experiences.
This study aims to evaluate the relationship between diet, gut microbiota, and clinical outcomes by comparing children with systemic lupus erythematosus (SLE) and healthy individuals living in the same household. The study will be conducted at the Pediatric Nephrology and Rheumatology Department of Erciyes University, including approximately 30 children diagnosed with SLE and 30 healthy family members.
The study will include an intervention group and a control group. Participants in the intervention group will receive individualized nutrition counseling based on the principles of the Mediterranean diet, provided by a registered dietitian. The intervention will focus on increasing dietary polyphenol intake, reducing dietary inflammatory potential, and limiting the consumption of ultra-processed foods. The counseling program will last for 12 weeks and include a total of 12 sessions. The first, sixth, and twelfth sessions will be conducted face-to-face, while the remaining sessions will be conducted via phone or online communication. The control group will not receive any dietary intervention.
At baseline and at the end of the study, stool samples will be collected from all participants for gut microbiota analysis. Anthropometric measurements and body composition analysis will be performed, and 3-day dietary records (including 2 weekdays and 1 weekend day) will be obtained. Diet quality, physical activity level, and sleep quality will be assessed using the Mediterranean Diet Quality Index for children and adolescents (KIDMED), the International Physical Activity Questionnaire-Short Form (IPAQ), and the Pittsburgh Sleep Quality Index (PSQI), respectively.
In addition, children with SLE will be evaluated using the Childhood Health Assessment Questionnaire (CHAQ), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), and the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SLICC/SDI). Biochemical parameters routinely collected during clinical follow-up will be obtained from patient records.
Dietary intake data will be analyzed using the BeBiS software. The dietary inflammatory index (DII), dietary polyphenol content (based on the Phenol-Explorer database), and the level of food processing (according to the NOVA classification) will be evaluated.
At the end of the intervention, a focus group discussion will be conducted with a subset of participants from the intervention group to explore their experiences and perceptions of the dietary intervention. Qualitative data obtained from these discussions will be analyzed using content analysis methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediterranean Diet-Based Individual Nutrition Counseling | Behavioral | 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/SDI(Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index). No food is provided; focus is on modifying existing habits. |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiota diversity | Changes in gut microbiota diversity assessed by 16S rRNA sequencing of stool samples. | Baseline (Week 0) and Week 12 |
| Change in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score | The SLEDAI-2K evaluates overall disease activity in children with systemic lupus erythematosus over the past 10 days. It includes 24 clinical and laboratory items across nine organ systems. Scores range from 0 to 105, with scores ≥6 indicating clinically significant disease activity. Assessment is conducted at baseline and at the final study visit. | Baseline and week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | Measured in kilograms (kg) at baseline, week 6, and week 12 using standardized protocols. | Baseline to 12 weeks |
| Change in Height | Measured in centimeters (cm) at baseline, week 6, and week 12 using standardized protocols. |
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Inclusion Criteria:
For participants with Systemic Lupus Erythematosus (SLE):
For healthy controls (household members):
Exclusion Criteria:
For participants with SLE:
For healthy controls (household members):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SABRIYE BALLI, MSc (PhD Candidate) | Contact | 0090-534-884-0893 | sabriyeballi@hotmail.com | |
| ZEYNEP CAFEROGLU AKIN, PhD | Contact | 0090-352-437-9282 | 28651 | zcaferoglu@erciyes.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| ZEYNEP CAFEROGLU AKIN, PhD | Erciyes University, Faculty of Health Sciences, Department of Nutrition and Dietetics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erciyes University Mustafa Eraslan and Fevzi Mercan Children's Hospital | Kayseri | Melikgazi | 38039 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19864399 | Background | Cavicchia PP, Steck SE, Hurley TG, Hussey JR, Ma Y, Ockene IS, Hebert JR. A new dietary inflammatory index predicts interval changes in serum high-sensitivity C-reactive protein. J Nutr. 2009 Dec;139(12):2365-72. doi: 10.3945/jn.109.114025. Epub 2009 Oct 28. | |
| 12910556 | Background | Ravelli A, Duarte-Salazar C, Buratti S, Reiff A, Bernstein B, Maldonado-Velazquez MR, Beristain-Manterola R, Maeno N, Takei S, Gerloni V, Spencer CH, Pratsidou-Gertsi P, Ruperto N, Pistorio A, Martini A. Assessment of damage in juvenile-onset systemic lupus erythematosus: a multicenter cohort study. Arthritis Rheum. 2003 Aug 15;49(4):501-7. doi: 10.1002/art.11205. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 26, 2025 | Apr 3, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 26, 2025 | Apr 3, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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This is a parallel-assignment interventional study. The intervention group includes children with SLE, and the control group includes their healthy family members living in the same household. The intervention group will receive individualized nutritional counseling based on the Mediterranean Diet for 12 weeks, aiming to increase polyphenol intake, reduce dietary inflammatory index, and limit ultra-processed foods. The control group will not receive any dietary intervention.
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| Baseline to 12 weeks |
| Change in Body Mass Index (BMI) | Calculated as weight (kg) divided by height squared (m²), reported in kg/m² at baseline, week 6, and week 12. | Baseline to 12 weeks |
| Change in Fat Mass | Measured in kilograms (kg) at baseline, week 6, and week 12 using standardized protocols. | Baseline to 12 weeks |
| Change in Muscle Mass | Measured in kilograms (kg) at baseline, week 6, and week 12 using standardized protocols. | Baseline to 12 weeks |
| Change in Body Fat Percentage | Measured as percentage (%) at baseline, week 6, and week 12 using standardized protocols. | Baseline to 12 weeks |
| Change in Muscle Mass Percentage | Measured as percentage (%) at baseline, week 6, and week 12 using standardized protocols. | Baseline to 12 weeks |
| Change in SLICC/ACR Damage Index (SLICC/SDI) Score | The SLICC/SDI evaluates accumulated organ damage in children with systemic lupus erythematosus, independent of current disease activity. It consists of 41 items across 12 organ systems, with total scores ranging from 0 to 49. Higher scores indicate greater organ damage. Assessment is conducted at baseline and at the final study visit. | Baseline and week 12 |
| Concentration of White Blood Cell Count (WBC) | WBC levels will be measured in ×10³/mm³ using routine laboratory tests obtained from patient records at Erciyes University Faculty of Medicine Children's Hospital. Values will be classified according to age-appropriate reference ranges. | Baseline and week 12 |
| Concentration of Hemoglobin (Hb) | Hemoglobin levels will be measured in g/dL using routine laboratory tests obtained from patient records at Erciyes University Faculty of Medicine Children's Hospital. Values will be classified according to age-appropriate reference ranges. | Baseline and week 12 |
| Concentration of Platelet Count | Platelet counts will be measured in ×10³/mm³ using routine laboratory tests obtained from patient records at Erciyes University Faculty of Medicine Children's Hospital. Values will be classified according to age-appropriate reference ranges. | Baseline and week 12 |
| Concentration of Blood Urea Nitrogen (BUN) | Serum BUN levels will be measured in mg/dL using routine laboratory tests obtained from patient records at Erciyes University Faculty of Medicine Children's Hospital. Values will be classified according to age-appropriate reference ranges. | Baseline and week 12 |
| Concentration of Creatinine | Serum creatinine levels will be measured in mg/dL using routine laboratory tests obtained from patient records at Erciyes University Faculty of Medicine Children's Hospital. Values will be classified according to age-appropriate reference ranges. | Baseline and week 12 |
| Concentration of Erythrocyte Sedimentation Rate (ESR) | ESR will be measured in mg/h using routine laboratory tests obtained from patient records at Erciyes University Faculty of Medicine Children's Hospital. Values will be classified according to age-appropriate reference ranges. | Baseline and week 12 |
| Concentration of C-Reactive Protein (CRP) | CRP levels will be measured in mg/L using routine laboratory tests obtained from patient records at Erciyes University Faculty of Medicine Children's Hospital. Values will be classified according to age-appropriate reference ranges. | Baseline to week 12 |
| Concentration of Calcium | Serum calcium levels will be measured in mg/dL using routine laboratory tests obtained from patient records at Erciyes University Faculty of Medicine Children's Hospital. Values will be classified according to age-appropriate reference ranges. | Baseline and week 12 |
| Concentration of Phosphorus | Serum phosphorus levels will be measured in mg/dL using routine laboratory tests obtained from patient records at Erciyes University Faculty of Medicine Children's Hospital. Values will be classified according to age-appropriate reference ranges. | Baseline and week 12 |
| Concentration of Alkaline Phosphatase (ALP) | ALP levels will be measured in U/L using routine laboratory tests obtained from patient records at Erciyes University Faculty of Medicine Children's Hospital. Values will be classified according to age-appropriate reference ranges. | Baseline and 12 week |
| Concentration of Parathyroid Hormone (PTH) | PTH levels will be measured in pg/mL using routine laboratory tests obtained from patient records at Erciyes University Faculty of Medicine Children's Hospital. Values will be classified according to age-appropriate reference ranges. | Baseline and week 12 |
| Concentration of 25-OH Vitamin D3 | Serum 25-OH vitamin D3 levels will be measured in ng/mL using routine laboratory tests obtained from patient records at Erciyes University Faculty of Medicine Children's Hospital. Values will be classified according to age-appropriate reference ranges. | Baseline and week 12 |
| Concentration of HbA1c | HbA1c levels will be measured as percentage (%) using routine laboratory tests obtained from patient records at Erciyes University Faculty of Medicine Children's Hospital. Values will be classified according to age-appropriate reference ranges. | Baseline and week 12 |
| Concentration of Total Cholesterol | Total cholesterol levels will be measured in mg/dL using routine laboratory tests obtained from patient records at Erciyes University Faculty of Medicine Children's Hospital. Values will be classified according to age-appropriate reference ranges. | Baseline and week 12 |
| Concentration of LDL Cholesterol | LDL cholesterol levels will be measured in mg/dL using routine laboratory tests obtained from patient records at Erciyes University Faculty of Medicine Children's Hospital. Values will be classified according to age-appropriate reference ranges. | Baseline and week 12 |
| Concentration of HDL Cholesterol | HDL cholesterol levels will be measured in mg/dL using routine laboratory tests obtained from patient records at Erciyes University Faculty of Medicine Children's Hospital. Values will be classified according to age-appropriate reference ranges. | Baseline and week 12 |
| Concentration of Triglycerides | Triglyceride levels will be measured in mg/dL using routine laboratory tests obtained from patient records at Erciyes University Faculty of Medicine Children's Hospital. Values will be classified according to age-appropriate reference ranges. | Baseline and week 12 |
| Concentration of Alanine Aminotransferase (ALT) | Alanine aminotransferase (ALT) levels will be measured in U/L using routine laboratory tests obtained from patient records at Erciyes University Faculty of Medicine Children's Hospital. Values will be classified according to age-appropriate reference ranges. | Baseline and week 12 |
| Concentration of Aspartate Aminotransferase (AST) | Aspartate aminotransferase (AST) levels will be measured in U/L using routine laboratory tests obtained from patient records at Erciyes University Faculty of Medicine Children's Hospital. Values will be classified according to age-appropriate reference ranges. | Baseline and week 12 |
| Concentration of Total Protein | Serum total protein levels will be measured in g/dL using routine laboratory tests obtained from patient records at Erciyes University Faculty of Medicine Children's Hospital. Values will be classified according to age-appropriate reference ranges. | Baseline and week 12 |
| Concentration of Albumin | Serum albumin levels will be measured in g/dL using routine laboratory tests obtained from patient records at Erciyes University Faculty of Medicine Children's Hospital. Values will be classified according to age-appropriate reference ranges. | Baseline and week 12 |
| Concentration of Complement C3 | C3 levels will be measured in mg/dL using routine laboratory tests obtained from patient records at Erciyes University Faculty of Medicine Children's Hospital. Values will be classified according to age-appropriate reference ranges. | Baseline and week 12 |
| Concentration of Complement C4 | C4 levels will be measured in mg/dL using routine laboratory tests obtained from patient records at Erciyes University Faculty of Medicine Children's Hospital. Values will be classified according to age-appropriate reference ranges. | Baseline and week 12 |
| Presence of Anti-dsDNA | Anti-dsDNA levels will be measured using standard laboratory units from routine patient records. Values will be classified according to age-appropriate reference ranges. | Baseline and week 12 |
| Result of Direct Coombs Test | Direct Coombs test results will be reported as positive or negative using routine laboratory records. | Baseline and week 12 |
| Presence of Anti-cardiolipin (ACA) IgG/IgM | ACA IgG/IgM levels will be measured in standardized units using routine laboratory tests obtained from patient records. | Baseline and week 12 |
| Presence of Anti-beta-2 glycoprotein I (AB2GP) IgG/IgA/IgM | AB2GP antibody levels will be measured in standardized units using routine laboratory tests obtained from patient records. | Baseline and week 12 |
| Result of Lupus Anticoagulant (LA) | LA status will be reported as positive or negative using routine laboratory records. | Baseline and week 12 |
| Value of Urine Protein/Creatinine Ratio | Urine protein/creatinine ratio will be measured in mg/mg using routine laboratory tests obtained from patient records. | Baseline and week 12 |
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