Mediterranean Diet and Gut Microbiota in Children With Systemic Lupus Erythematosus (NCT07555626) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Mediterranean Diet and Gut Microbiota in Children With Systemic Lupus Erythematosus
Turkey (Türkiye)60 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range
8 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Gut microbiota diversity
Timeframe: Baseline (Week 0) and Week 12
2
Change in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score