Systemic Lupus Erythematosus (SLE)
Conditions
Keywords
Mediterranean Diet, Systemic Lupus Erythematosus, Gut microbiota, Individual nutrition counseling, Child
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMediterranean 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/SDI(Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index). No food is provided; focus is on modifying existing habits.
Sponsors
TC Erciyes University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
For participants with Systemic Lupus Erythematosus (SLE): * Diagnosis of SLE according to the SLICC classification criteria. * SLE diagnosis established at least 6 months prior to enrollment. For healthy controls (household members): * Living in the same household as participants with SLE. * Body mass index (BMI) within the normal range.
Exclusion criteria
For participants with SLE: * Presence of active infection. * Renal failure, or history of major trauma or surgery within the past 6 months. * Presence of additional chronic diseases other than SLE. * Use of antibiotics or probiotics within the past 4 weeks. * Following a specific or restrictive diet. * Illiteracy or cognitive impairment that may limit understanding of the intervention. For healthy controls (household members): * Presence of active infection * Presence of any chronic disease * Use of antibiotics or probiotics within the past 4 weeks * Following a specific or restrictive diet * Illiteracy or cognitive impairment that may limit understanding of study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiota diversity | Baseline (Week 0) and Week 12 | Changes in gut microbiota diversity assessed by 16S rRNA sequencing of stool samples. |
| Change in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score | Baseline and week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | Baseline to 12 weeks | Measured in kilograms (kg) at baseline, week 6, and week 12 using standardized protocols. |
| Change in Height | Baseline to 12 weeks | Measured in centimeters (cm) at baseline, week 6, and week 12 using standardized protocols. |
| Change in Body Mass Index (BMI) | Baseline to 12 weeks | Calculated as weight (kg) divided by height squared (m²), reported in kg/m² at baseline, week 6, and week 12. |
| Change in Fat Mass | Baseline to 12 weeks | Measured in kilograms (kg) at baseline, week 6, and week 12 using standardized protocols. |
| Change in Muscle Mass | Baseline to 12 weeks | Measured in kilograms (kg) at baseline, week 6, and week 12 using standardized protocols. |
| Change in Body Fat Percentage | Baseline to 12 weeks | Measured as percentage (%) at baseline, week 6, and week 12 using standardized protocols. |
| Change in Muscle Mass Percentage | Baseline to 12 weeks | Measured as percentage (%) at baseline, week 6, and week 12 using standardized protocols. |
| Change in SLICC/ACR Damage Index (SLICC/SDI) Score | Baseline and week 12 | 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. |
| Concentration of White Blood Cell Count (WBC) | Baseline and week 12 | 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. |
| Concentration of Hemoglobin (Hb) | Baseline and week 12 | 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. |
| Concentration of Platelet Count | Baseline and week 12 | 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. |
| Concentration of Blood Urea Nitrogen (BUN) | Baseline and week 12 | 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. |
| Concentration of Creatinine | Baseline and week 12 | 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. |
| Concentration of Erythrocyte Sedimentation Rate (ESR) | Baseline and week 12 | 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. |
| Concentration of C-Reactive Protein (CRP) | Baseline to week 12 | 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. |
| Concentration of Calcium | Baseline and week 12 | 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. |
| Concentration of Phosphorus | Baseline and week 12 | 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. |
| Concentration of Alkaline Phosphatase (ALP) | Baseline and 12 week | 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. |
| Concentration of Parathyroid Hormone (PTH) | Baseline and week 12 | 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. |
| Concentration of 25-OH Vitamin D3 | Baseline and week 12 | 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. |
| Concentration of HbA1c | Baseline and week 12 | 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. |
| Concentration of Total Cholesterol | Baseline and week 12 | 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. |
| Concentration of LDL Cholesterol | Baseline and week 12 | 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. |
| Concentration of HDL Cholesterol | Baseline and week 12 | 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. |
| Concentration of Triglycerides | Baseline and week 12 | 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. |
| Concentration of Alanine Aminotransferase (ALT) | Baseline and week 12 | 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. |
| Concentration of Aspartate Aminotransferase (AST) | Baseline and week 12 | 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. |
| Concentration of Total Protein | Baseline and week 12 | 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. |
| Concentration of Albumin | Baseline and week 12 | 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. |
| Concentration of Complement C3 | Baseline and week 12 | 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. |
| Concentration of Complement C4 | Baseline and week 12 | 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. |
| Presence of Anti-dsDNA | Baseline and week 12 | Anti-dsDNA levels will be measured using standard laboratory units from routine patient records. Values will be classified according to age-appropriate reference ranges. |
| Result of Direct Coombs Test | Baseline and week 12 | Direct Coombs test results will be reported as positive or negative using routine laboratory records. |
| Presence of Anti-cardiolipin (ACA) IgG/IgM | Baseline and week 12 | ACA IgG/IgM levels will be measured in standardized units using routine laboratory tests obtained from patient records. |
| Presence of Anti-beta-2 glycoprotein I (AB2GP) IgG/IgA/IgM | Baseline and week 12 | AB2GP antibody levels will be measured in standardized units using routine laboratory tests obtained from patient records. |
| Result of Lupus Anticoagulant (LA) | Baseline and week 12 | LA status will be reported as positive or negative using routine laboratory records. |
| Value of Urine Protein/Creatinine Ratio | Baseline and week 12 | Urine protein/creatinine ratio will be measured in mg/mg using routine laboratory tests obtained from patient records. |
Countries
Turkey (Türkiye)
Contacts
CONTACTSABRIYE BALLI, MSc (PhD Candidate)
CONTACTZEYNEP CAFEROGLU AKIN, PhD
PRINCIPAL_INVESTIGATORZEYNEP CAFEROGLU AKIN, PhD
Erciyes University, Faculty of Health Sciences, Department of Nutrition and Dietetics
Outcome results
None listed