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NCT Number: NCT07555626

Mediterranean Diet and Gut Microbiota in Children With Systemic Lupus Erythematosus

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.

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Key information

Conditions

Systemic Lupus Erythematosus (SLE) Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University Mustafa Eraslan and Fevzi Mercan Children's Hospital

Kayseri, Melikgazi, 38039, Turkey (Türkiye)

Location contact

AYSENUR PAC KISAARSLAN, MD

CONTACT

[email protected]

0090-352-207-6666 ext. 25476

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Gut microbiota diversity

    Time frame: Baseline (Week 0) and Week 12

    Changes in gut microbiota diversity assessed by 16S rRNA sequencing of stool samples.

  2. Change in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score

    Time frame: 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 outcomes

  1. Change in Body Weight

    Time frame: Baseline to 12 weeks

    Measured in kilograms (kg) at baseline, week 6, and week 12 using standardized protocols.

  2. Change in Height

    Time frame: Baseline to 12 weeks

    Measured in centimeters (cm) at baseline, week 6, and week 12 using standardized protocols.

  3. Change in Body Mass Index (BMI)

    Time frame: Baseline to 12 weeks

    Calculated as weight (kg) divided by height squared (m²), reported in kg/m² at baseline, week 6, and week 12.

  4. Change in Fat Mass

    Time frame: Baseline to 12 weeks

    Measured in kilograms (kg) at baseline, week 6, and week 12 using standardized protocols.

  5. Change in Muscle Mass

    Time frame: Baseline to 12 weeks

    Measured in kilograms (kg) at baseline, week 6, and week 12 using standardized protocols.

  6. Change in Body Fat Percentage

    Time frame: Baseline to 12 weeks

    Measured as percentage (%) at baseline, week 6, and week 12 using standardized protocols.

  7. Change in Muscle Mass Percentage

    Time frame: Baseline to 12 weeks

    Measured as percentage (%) at baseline, week 6, and week 12 using standardized protocols.

  8. Change in SLICC/ACR Damage Index (SLICC/SDI) Score

    Time frame: 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.

  9. Concentration of White Blood Cell Count (WBC)

    Time frame: 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.

  10. Concentration of Hemoglobin (Hb)

    Time frame: 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.

  11. Concentration of Platelet Count

    Time frame: 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.

  12. Concentration of Blood Urea Nitrogen (BUN)

    Time frame: 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.

  13. Concentration of Creatinine

    Time frame: 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.

  14. Concentration of Erythrocyte Sedimentation Rate (ESR)

    Time frame: 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.

  15. Concentration of C-Reactive Protein (CRP)

    Time frame: 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.

  16. Concentration of Calcium

    Time frame: 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.

  17. Concentration of Phosphorus

    Time frame: 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.

  18. Concentration of Alkaline Phosphatase (ALP)

    Time frame: 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.

  19. Concentration of Parathyroid Hormone (PTH)

    Time frame: 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.

  20. Concentration of 25-OH Vitamin D3

    Time frame: 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.

  21. Concentration of HbA1c

    Time frame: 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.

  22. Concentration of Total Cholesterol

    Time frame: 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.

  23. Concentration of LDL Cholesterol

    Time frame: 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.

  24. Concentration of HDL Cholesterol

    Time frame: 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.

  25. Concentration of Triglycerides

    Time frame: 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.

  26. Concentration of Alanine Aminotransferase (ALT)

    Time frame: 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.

  27. Concentration of Aspartate Aminotransferase (AST)

    Time frame: 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.

  28. Concentration of Total Protein

    Time frame: 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.

  29. Concentration of Albumin

    Time frame: 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.

  30. Concentration of Complement C3

    Time frame: 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.

  31. Concentration of Complement C4

    Time frame: 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.

  32. Presence of Anti-dsDNA

    Time frame: 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.

  33. Result of Direct Coombs Test

    Time frame: Baseline and week 12

    Direct Coombs test results will be reported as positive or negative using routine laboratory records.

  34. Presence of Anti-cardiolipin (ACA) IgG/IgM

    Time frame: Baseline and week 12

    ACA IgG/IgM levels will be measured in standardized units using routine laboratory tests obtained from patient records.

  35. Presence of Anti-beta-2 glycoprotein I (AB2GP) IgG/IgA/IgM

    Time frame: Baseline and week 12

    AB2GP antibody levels will be measured in standardized units using routine laboratory tests obtained from patient records.

  36. Result of Lupus Anticoagulant (LA)

    Time frame: Baseline and week 12

    LA status will be reported as positive or negative using routine laboratory records.

  37. Value of Urine Protein/Creatinine Ratio

    Time frame: Baseline and week 12

    Urine protein/creatinine ratio will be measured in mg/mg using routine laboratory tests obtained from patient records.

Study contacts

Contact information is provided by the study sponsor or research team.

SABRIYE BALLI, MSc (PhD Candidate)

CONTACT

[email protected]

0090-534-884-0893

ZEYNEP CAFEROGLU AKIN, PhD

CONTACT

[email protected]

0090-352-437-9282 ext. 28651

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

Effects of a Mediterranean Diet-Based Nutritional Intervention on Gut Microbiota, Disease Activity, and Nutritional Status in Children With Systemic Lupus Erythematosus

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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