NCT07555626Not yet recruiting
Mediterranean Diet and Gut Microbiota in Children With Systemic Lupus Erythematosus
Effects of a Mediterranean Diet-Based Nutritional Intervention on Gut Microbiota, Disease Activity, and Nutritional Status in Children With Systemic Lupus Erythematosus
Source: ClinicalTrials.gov · Last updated 29 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 6 Apr 2026
- Start date
- Jun 2026
- Primary completion date
- Oct 2027
- Lead sponsor
- TC Erciyes University
- Diseases
- Lupus (SLE)
- NCT number
- NCT07555626
What you commit to
- Study type: Interventional
- Planned participants: 60
- From Jun 2026 to the primary completion date, Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- 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
- Illiteracy or cognitive impairment that may limit understanding of study procedures
Other
- For participants with SLE:
- Use of antibiotics or probiotics within the past 4 weeks.
- Following a specific or restrictive diet.
- Use of antibiotics or probiotics within the past 4 weeks
- Following a specific or restrictive diet
Who the study is looking for
- 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.
Age in the registry: 8 years to 18 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Erciyes University Mustafa Eraslan and Fevzi Mercan Children's Hospital Coordinator of this site? Confirm its status | Kayseri | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.