Mediterranean Diet and Gut Microbiota in Children With Systemic Lupus Erythematosus

April 21, 2026 updated by: Sabriye BALLI, TC Erciyes University

Effects of a Mediterranean Diet-Based Nutritional Intervention on Gut Microbiota, Disease Activity, and Nutritional Status 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Melikgazi
      • Kayseri, Melikgazi, Turkey (Türkiye), 38039
        • Erciyes University Mustafa Eraslan and Fevzi Mercan Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mediterranean Diet Intervention Group
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.
Behavioral: Mediterranean 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.
No Intervention: Healthy Household Control Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut microbiota diversity
Time Frame: Baseline (Week 0) and Week 12
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
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.
Baseline and week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Weight
Time Frame: Baseline to 12 weeks
Measured in kilograms (kg) at baseline, week 6, and week 12 using standardized protocols.
Baseline to 12 weeks
Change in Height
Time Frame: Baseline to 12 weeks
Measured in centimeters (cm) at baseline, week 6, and week 12 using standardized protocols.
Baseline to 12 weeks
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.
Baseline to 12 weeks
Change in Fat Mass
Time Frame: Baseline to 12 weeks
Measured in kilograms (kg) at baseline, week 6, and week 12 using standardized protocols.
Baseline to 12 weeks
Change in Muscle Mass
Time Frame: Baseline to 12 weeks
Measured in kilograms (kg) at baseline, week 6, and week 12 using standardized protocols.
Baseline to 12 weeks
Change in Body Fat Percentage
Time Frame: Baseline to 12 weeks
Measured as percentage (%) at baseline, week 6, and week 12 using standardized protocols.
Baseline to 12 weeks
Change in Muscle Mass Percentage
Time Frame: Baseline to 12 weeks
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
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.
Baseline and week 12
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.
Baseline and week 12
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.
Baseline and week 12
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.
Baseline and week 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.
Baseline and week 12
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.
Baseline and week 12
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.
Baseline and week 12
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.
Baseline to week 12
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.
Baseline and week 12
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.
Baseline and week 12
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.
Baseline and 12 week
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.
Baseline and week 12
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.
Baseline and week 12
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.
Baseline and week 12
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.
Baseline and week 12
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.
Baseline and week 12
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.
Baseline and week 12
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.
Baseline and week 12
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.
Baseline and week 12
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.
Baseline and week 12
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.
Baseline and week 12
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.
Baseline and week 12
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.
Baseline and week 12
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.
Baseline and week 12
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.
Baseline and week 12
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.
Baseline and week 12
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.
Baseline and week 12
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.
Baseline and week 12
Result of Lupus Anticoagulant (LA)
Time Frame: Baseline and week 12
LA status will be reported as positive or negative using routine laboratory records.
Baseline and week 12
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.
Baseline and week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Investigators

  • Principal Investigator: ZEYNEP CAFEROGLU AKIN, PhD, Erciyes University, Faculty of Health Sciences, Department of Nutrition and Dietetics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

April 6, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDK-2026-15829

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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