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.
Diagnosis of SLE according to the SLICC classification criteria.
SLE diagnosis established at least 6 months prior to enrollment.
Living in the same household as participants with SLE.
Body mass index (BMI) within the normal range.
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.
Parallel
Mediterranean Diet-Based Individual Nutrition Counseling
BehavioralParticipants 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.
Gut microbiota diversity
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
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.
Change in Body Weight
Measured in kilograms (kg) at baseline, week 6, and week 12 using standardized protocols.
Change in Height
Measured in centimeters (cm) at baseline, week 6, and week 12 using standardized protocols.
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.
Change in Fat Mass
Measured in kilograms (kg) at baseline, week 6, and week 12 using standardized protocols.
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This trial is not recruiting at the moment. You can still explore other options:
