Systemic Lupus Erythematosus (SLE)NCT07555626
Mediterranean Diet and Gut Microbiota in Children With Systemic Lupus Erythematosus
A study testing Mediterranean Diet-Based Individual Nutrition Counseling in people with Systemic Lupus Erythematosus (SLE), run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE)
- What is being tested?
- Mediterranean Diet-Based Individual Nutrition Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2026to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Erciyes University Mustafa Eraslan and Fevzi Mercan Children's Hospital
Kayseri, Melikgazi, 38039
AYSENUR PAC KISAARSLAN, MD, 0090-352-207-6666 ext. 25476, apkisaarslan@erciyes.edu.tr
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Being tested
- Mediterranean Diet-Based Individual Nutrition Counseling
- Keywords
- Mediterranean Diet, Systemic Lupus Erythematosus, Gut microbiota, Individual nutrition counseling, Child
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean Diet-Based Individual Nutrition CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiota diversity
Changes in gut microbiota diversity assessed by 16S rRNA sequencing of stool samples.
Measured: 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.
Measured: Baseline and week 12
Secondary outcomes (37)
Change in Body Weight
Measured in kilograms (kg) at baseline, week 6, and week 12 using standardized protocols.
Measured: Baseline to 12 weeks
Change in Height
Measured in centimeters (cm) at baseline, week 6, and week 12 using standardized protocols.
Measured: Baseline to 12 weeks
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.
Measured: Baseline to 12 weeks
Change in Fat Mass
Measured in kilograms (kg) at baseline, week 6, and week 12 using standardized protocols.
Measured: Baseline to 12 weeks
Change in Muscle Mass
Measured in kilograms (kg) at baseline, week 6, and week 12 using standardized protocols.
Measured: Baseline to 12 weeks
Change in Body Fat Percentage
Measured as percentage (%) at baseline, week 6, and week 12 using standardized protocols.
Measured: Baseline to 12 weeks
Change in Muscle Mass Percentage
Measured as percentage (%) at baseline, week 6, and week 12 using standardized protocols.
Measured: Baseline to 12 weeks
Change in SLICC/ACR Damage Index (SLICC/SDI) Score
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.
Measured: Baseline and week 12
Concentration of White Blood Cell Count (WBC)
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.
Measured: Baseline and week 12
Concentration of Hemoglobin (Hb)
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.
Measured: Baseline and week 12
Concentration of Platelet Count
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.
Measured: Baseline and week 12
Concentration of Blood Urea Nitrogen (BUN)
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.
Measured: Baseline and week 12
Concentration of Creatinine
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.
Measured: Baseline and week 12
Concentration of Erythrocyte Sedimentation Rate (ESR)
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.
Measured: Baseline and week 12
Concentration of C-Reactive Protein (CRP)
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.
Measured: Baseline to week 12
Concentration of Calcium
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.
Measured: Baseline and week 12
Concentration of Phosphorus
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.
Measured: Baseline and week 12
Concentration of Alkaline Phosphatase (ALP)
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.
Measured: Baseline and 12 week
Concentration of Parathyroid Hormone (PTH)
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.
Measured: Baseline and week 12
Concentration of 25-OH Vitamin D3
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.
Measured: Baseline and week 12
Concentration of HbA1c
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.
Measured: Baseline and week 12
Concentration of Total Cholesterol
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.
Measured: Baseline and week 12
Concentration of LDL Cholesterol
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.
Measured: Baseline and week 12
Concentration of HDL Cholesterol
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.
Measured: Baseline and week 12
Concentration of Triglycerides
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.
Measured: Baseline and week 12
Concentration of Alanine Aminotransferase (ALT)
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.
Measured: Baseline and week 12
Concentration of Aspartate Aminotransferase (AST)
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.
Measured: Baseline and week 12
Concentration of Total Protein
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.
Measured: Baseline and week 12
Concentration of Albumin
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.
Measured: Baseline and week 12
Concentration of Complement C3
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.
Measured: Baseline and week 12
Concentration of Complement C4
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.
Measured: Baseline and week 12
Presence of Anti-dsDNA
Anti-dsDNA levels will be measured using standard laboratory units from routine patient records. Values will be classified according to age-appropriate reference ranges.
Measured: Baseline and week 12
Result of Direct Coombs Test
Direct Coombs test results will be reported as positive or negative using routine laboratory records.
Measured: Baseline and week 12
Presence of Anti-cardiolipin (ACA) IgG/IgM
ACA IgG/IgM levels will be measured in standardized units using routine laboratory tests obtained from patient records.
Measured: Baseline and week 12
Presence of Anti-beta-2 glycoprotein I (AB2GP) IgG/IgA/IgM
AB2GP antibody levels will be measured in standardized units using routine laboratory tests obtained from patient records.
Measured: Baseline and week 12
Result of Lupus Anticoagulant (LA)
LA status will be reported as positive or negative using routine laboratory records.
Measured: Baseline and week 12
Value of Urine Protein/Creatinine Ratio
Urine protein/creatinine ratio will be measured in mg/mg using routine laboratory tests obtained from patient records.
Measured: Baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study startJun 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabriye BALLI, TC Erciyes University
- Investigators
- ZEYNEP CAFEROGLU AKIN, PhD, Principal investigator, Erciyes University, Faculty of Health Sciences, Department of Nutrition and Dietetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555626
- Sponsor's protocol ID
- TDK-2026-15829
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cavicchia PP, Steck SE, Hurley TG, Hussey JR, Ma Y, Ockene IS, Hebert JR. A new dietary inflammatory index predicts interval changes in serum high-sensitivity C-reactive protein. J Nutr. 2009 Dec;139(12):2365-72. doi: 10.3945/jn.109.114025. Epub 2009 Oct 28.
PubMed 19864399Ravelli A, Duarte-Salazar C, Buratti S, Reiff A, Bernstein B, Maldonado-Velazquez MR, Beristain-Manterola R, Maeno N, Takei S, Gerloni V, Spencer CH, Pratsidou-Gertsi P, Ruperto N, Pistorio A, Martini A. Assessment of damage in juvenile-onset systemic lupus erythematosus: a multicenter cohort study. Arthritis Rheum. 2003 Aug 15;49(4):501-7. doi: 10.1002/art.11205.
PubMed 12910556Stoll T, Seifert B, Isenberg DA. SLICC/ACR Damage Index is valid, and renal and pulmonary organ scores are predictors of severe outcome in patients with systemic lupus erythematosus. Br J Rheumatol. 1996 Mar;35(3):248-54. doi: 10.1093/rheumatology/35.3.248.
PubMed 8620300Stoll T, Sutcliffe N, Mach J, Klaghofer R, Isenberg DA. Analysis of the relationship between disease activity and damage in patients with systemic lupus erythematosus--a 5-yr prospective study. Rheumatology (Oxford). 2004 Aug;43(8):1039-44. doi: 10.1093/rheumatology/keh238. Epub 2004 May 25.
PubMed 15161983Urowitz MB, Gladman DD. Measures of disease activity and damage in SLE. Baillieres Clin Rheumatol. 1998 Aug;12(3):405-13. doi: 10.1016/s0950-3579(98)80027-7.
PubMed 9890104Eder L, Urowitz MB, Gladman DD. Damage in lupus patients--what have we learned so far? Lupus. 2013 Oct;22(12):1225-31. doi: 10.1177/0961203313492872.
PubMed 24097994Gladman D, Ginzler E, Goldsmith C, Fortin P, Liang M, Urowitz M, Bacon P, Bombardieri S, Hanly J, Hay E, Isenberg D, Jones J, Kalunian K, Maddison P, Nived O, Petri M, Richter M, Sanchez-Guerrero J, Snaith M, Sturfelt G, Symmons D, Zoma A. The development and initial validation of the Systemic Lupus International Collaborating Clinics/American College of Rheumatology damage index for systemic lupus erythematosus. Arthritis Rheum. 1996 Mar;39(3):363-9. doi: 10.1002/art.1780390303.
PubMed 8607884Gladman DD, Ibanez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002 Feb;29(2):288-91.
PubMed 11838846Singh G, Athreya BH, Fries JF, Goldsmith DP. Measurement of health status in children with juvenile rheumatoid arthritis. Arthritis Rheum. 1994 Dec;37(12):1761-9. doi: 10.1002/art.1780371209.
PubMed 7986222Ozdogan H, Ruperto N, Kasapcopur O, Bakkaloglu A, Arisoy N, Ozen S, Ugurlu U, Unsal E, Melikoglu M; Paediatric Rheumatology International Trials Organisation. The Turkish version of the Childhood Health Assessment Questionnaire (CHAQ) and the Child Health Questionnaire (CHQ). Clin Exp Rheumatol. 2001 Jul-Aug;19(4 Suppl 23):S158-62.
PubMed 11510322Meiorin S, Pistorio A, Ravelli A, Iusan SM, Filocamo G, Trail L, Oliveira S, Cuttica R, Espada G, Alessio M, Mihaylova D, Cortis E, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation. Validation of the Childhood Health Assessment Questionnaire in active juvenile systemic lupus erythematosus. Arthritis Rheum. 2008 Aug 15;59(8):1112-9. doi: 10.1002/art.23912.
PubMed 18668598Ramey DR, Raynauld JP, Fries JF. The health assessment questionnaire 1992: status and review. Arthritis Care Res. 1992 Sep;5(3):119-29. doi: 10.1002/art.1790050303.
PubMed 1457486Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 12900694Serra-Majem L, Ribas L, Ngo J, Ortega RM, Garcia A, Perez-Rodrigo C, Aranceta J. Food, youth and the Mediterranean diet in Spain. Development of KIDMED, Mediterranean Diet Quality Index in children and adolescents. Public Health Nutr. 2004 Oct;7(7):931-5. doi: 10.1079/phn2004556.
PubMed 15482620
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Mediterranean Diet-Based Nutritional Intervention on Gut Microbiota, Disease Activity, and Nutritional Status in Children With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07555626
- Acronym / sponsor ID
- TDK-2026-15829
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Keywords
- Mediterranean Diet, Systemic Lupus Erythematosus, Gut microbiota, Individual nutrition counseling, Child
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet Intervention Group | Experimental | Behavioral: Mediterranean Diet-Based Individual Nutrition CounselingParticipants 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. |
| 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean Diet-Based Individual Nutrition CounselingParticipants 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. | Behavioural | Mediterranean Diet Intervention Group |
Primary outcome
Gut microbiota diversity
Time frame: 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
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.
37 secondary outcomes
Change in Body Weight
Time frame: Baseline to 12 weeks
Change in Height
Time frame: Baseline to 12 weeks
Change in Body Mass Index (BMI)
Time frame: Baseline to 12 weeks
Change in Fat Mass
Time frame: Baseline to 12 weeks
Change in Muscle Mass
Time frame: Baseline to 12 weeks
Change in Body Fat Percentage
Time frame: Baseline to 12 weeks
Change in Muscle Mass Percentage
Time frame: Baseline to 12 weeks
Change in SLICC/ACR Damage Index (SLICC/SDI) Score
Time frame: Baseline and week 12
Concentration of White Blood Cell Count (WBC)
Time frame: Baseline and week 12
Concentration of Hemoglobin (Hb)
Time frame: Baseline and week 12
Concentration of Platelet Count
Time frame: Baseline and week 12
Concentration of Blood Urea Nitrogen (BUN)
Time frame: Baseline and week 12
Concentration of Creatinine
Time frame: Baseline and week 12
Concentration of Erythrocyte Sedimentation Rate (ESR)
Time frame: Baseline and week 12
Concentration of C-Reactive Protein (CRP)
Time frame: Baseline to week 12
Concentration of Calcium
Time frame: Baseline and week 12
Concentration of Phosphorus
Time frame: Baseline and week 12
Concentration of Alkaline Phosphatase (ALP)
Time frame: Baseline and 12 week
Concentration of Parathyroid Hormone (PTH)
Time frame: Baseline and week 12
Concentration of 25-OH Vitamin D3
Time frame: Baseline and week 12
Concentration of HbA1c
Time frame: Baseline and week 12
Concentration of Total Cholesterol
Time frame: Baseline and week 12
Concentration of LDL Cholesterol
Time frame: Baseline and week 12
Concentration of HDL Cholesterol
Time frame: Baseline and week 12
Concentration of Triglycerides
Time frame: Baseline and week 12
Concentration of Alanine Aminotransferase (ALT)
Time frame: Baseline and week 12
Concentration of Aspartate Aminotransferase (AST)
Time frame: Baseline and week 12
Concentration of Total Protein
Time frame: Baseline and week 12
Concentration of Albumin
Time frame: Baseline and week 12
Concentration of Complement C3
Time frame: Baseline and week 12
Concentration of Complement C4
Time frame: Baseline and week 12
Presence of Anti-dsDNA
Time frame: Baseline and week 12
Result of Direct Coombs Test
Time frame: Baseline and week 12
Presence of Anti-cardiolipin (ACA) IgG/IgM
Time frame: Baseline and week 12
Presence of Anti-beta-2 glycoprotein I (AB2GP) IgG/IgA/IgM
Time frame: Baseline and week 12
Result of Lupus Anticoagulant (LA)
Time frame: Baseline and week 12
Value of Urine Protein/Creatinine Ratio
Time frame: Baseline and week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 19864399Cavicchia PP, Steck SE, Hurley TG, Hussey JR, Ma Y, Ockene IS, Hebert JR. A new dietary inflammatory index predicts interval changes in serum high-sensitivity C-reactive protein. J Nutr. 2009 Dec;139(12):2365-72. doi: 10.3945/jn.109.114025. Epub 2009 Oct 28.
- Background: PubMed 12910556Ravelli A, Duarte-Salazar C, Buratti S, Reiff A, Bernstein B, Maldonado-Velazquez MR, Beristain-Manterola R, Maeno N, Takei S, Gerloni V, Spencer CH, Pratsidou-Gertsi P, Ruperto N, Pistorio A, Martini A. Assessment of damage in juvenile-onset systemic lupus erythematosus: a multicenter cohort study. Arthritis Rheum. 2003 Aug 15;49(4):501-7. doi: 10.1002/art.11205.
- Background: PubMed 8620300Stoll T, Seifert B, Isenberg DA. SLICC/ACR Damage Index is valid, and renal and pulmonary organ scores are predictors of severe outcome in patients with systemic lupus erythematosus. Br J Rheumatol. 1996 Mar;35(3):248-54. doi: 10.1093/rheumatology/35.3.248.
- Background: PubMed 15161983Stoll T, Sutcliffe N, Mach J, Klaghofer R, Isenberg DA. Analysis of the relationship between disease activity and damage in patients with systemic lupus erythematosus--a 5-yr prospective study. Rheumatology (Oxford). 2004 Aug;43(8):1039-44. doi: 10.1093/rheumatology/keh238. Epub 2004 May 25.
- Background: PubMed 9890104Urowitz MB, Gladman DD. Measures of disease activity and damage in SLE. Baillieres Clin Rheumatol. 1998 Aug;12(3):405-13. doi: 10.1016/s0950-3579(98)80027-7.
- Background: PubMed 24097994Eder L, Urowitz MB, Gladman DD. Damage in lupus patients--what have we learned so far? Lupus. 2013 Oct;22(12):1225-31. doi: 10.1177/0961203313492872.
- Background: PubMed 8607884Gladman D, Ginzler E, Goldsmith C, Fortin P, Liang M, Urowitz M, Bacon P, Bombardieri S, Hanly J, Hay E, Isenberg D, Jones J, Kalunian K, Maddison P, Nived O, Petri M, Richter M, Sanchez-Guerrero J, Snaith M, Sturfelt G, Symmons D, Zoma A. The development and initial validation of the Systemic Lupus International Collaborating Clinics/American College of Rheumatology damage index for systemic lupus erythematosus. Arthritis Rheum. 1996 Mar;39(3):363-9. doi: 10.1002/art.1780390303.
- Background: PubMed 11838846Gladman DD, Ibanez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002 Feb;29(2):288-91.
- Background: PubMed 7986222Singh G, Athreya BH, Fries JF, Goldsmith DP. Measurement of health status in children with juvenile rheumatoid arthritis. Arthritis Rheum. 1994 Dec;37(12):1761-9. doi: 10.1002/art.1780371209.
- Background: PubMed 11510322Ozdogan H, Ruperto N, Kasapcopur O, Bakkaloglu A, Arisoy N, Ozen S, Ugurlu U, Unsal E, Melikoglu M; Paediatric Rheumatology International Trials Organisation. The Turkish version of the Childhood Health Assessment Questionnaire (CHAQ) and the Child Health Questionnaire (CHQ). Clin Exp Rheumatol. 2001 Jul-Aug;19(4 Suppl 23):S158-62.
- Background: PubMed 18668598Meiorin S, Pistorio A, Ravelli A, Iusan SM, Filocamo G, Trail L, Oliveira S, Cuttica R, Espada G, Alessio M, Mihaylova D, Cortis E, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation. Validation of the Childhood Health Assessment Questionnaire in active juvenile systemic lupus erythematosus. Arthritis Rheum. 2008 Aug 15;59(8):1112-9. doi: 10.1002/art.23912.
- Background: PubMed 1457486Ramey DR, Raynauld JP, Fries JF. The health assessment questionnaire 1992: status and review. Arthritis Care Res. 1992 Sep;5(3):119-29. doi: 10.1002/art.1790050303.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ZEYNEP CAFEROGLU AKIN, PhD principal investigator
Erciyes University, Faculty of Health Sciences, Department of Nutrition and Dietetics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean Diet-Based Individual Nutrition Counseling in people with Systemic Lupus Erythematosus (SLE), run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SABRIYE BALLI, MSc (PhD Candidate) (0090-534-884-0893, sabriyeballi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiota diversity (time frame: Baseline (Week 0) and Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07555626, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.