Mediterranean Diet and Gut Microbiota in Children With Systemic Lupus Erythematosus

NCT07555626 | Not Yet Recruiting

• 1 other identifier: TDK-2026-15829
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus (SLE)

Keywords

Mediterranean Diet; Systemic Lupus Erythematosus; Gut microbiota; Individual nutrition counseling; Child

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (37)

• Change in Body Weight

  Baseline to 12 weeks

• Change in Height

  Baseline to 12 weeks

• Change in Body Mass Index (BMI)

  Baseline to 12 weeks

• Change in Fat Mass

  Baseline to 12 weeks

• Change in Muscle Mass

  Baseline to 12 weeks

Study Arms (2)

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.

Behavioral: Mediterranean Diet-Based Individual Nutrition Counseling

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.

Interventions

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.

Mediterranean Diet Intervention Group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University Mustafa Eraslan and Fevzi Mercan Children's Hospital

Kayseri, Melikgazi, 38039, Turkey (Türkiye)

Location

Related Publications (27)

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Related Links

• Related Info

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• ZEYNEP CAFEROGLU AKIN, PhD

  Erciyes University, Faculty of Health Sciences, Department of Nutrition and Dietetics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SABRIYE BALLI, MSc (PhD Candidate)

CONTACT

0090-534-884-0893; sabriyeballi@hotmail.com

ZEYNEP CAFEROGLU AKIN, PhD

CONTACT

0090-352-437-9282; zcaferoglu@erciyes.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 29, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): February 1, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

TU (1)