Effects of a Mediterranean Diet-Based Nutritional Intervention on Gut Microbiota, Disease Activity, and Nutritional Status in Children With Systemic Lupus Erythematosus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Gut microbiota diversity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Mediterranean Diet-Based Individual Nutrition Counseling (Behavioral)
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.
结局指标
主要结局
Gut microbiota diversity
时间窗: 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
时间窗: 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.
次要结局
- 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)
- Change in Body Fat Percentage(Baseline to 12 weeks)
- Change in Muscle Mass Percentage(Baseline to 12 weeks)
- Change in SLICC/ACR Damage Index (SLICC/SDI) Score(Baseline and week 12)
- Concentration of White Blood Cell Count (WBC)(Baseline and week 12)
- Concentration of Hemoglobin (Hb)(Baseline and week 12)
- Concentration of Platelet Count(Baseline and week 12)
- Concentration of Blood Urea Nitrogen (BUN)(Baseline and week 12)
- Concentration of Creatinine(Baseline and week 12)
- Concentration of Erythrocyte Sedimentation Rate (ESR)(Baseline and week 12)
- Concentration of C-Reactive Protein (CRP)(Baseline to week 12)
- Concentration of Calcium(Baseline and week 12)
- Concentration of Phosphorus(Baseline and week 12)
- Concentration of Alkaline Phosphatase (ALP)(Baseline and 12 week)
- Concentration of Parathyroid Hormone (PTH)(Baseline and week 12)
- Concentration of 25-OH Vitamin D3(Baseline and week 12)
- Concentration of HbA1c(Baseline and week 12)
- Concentration of Total Cholesterol(Baseline and week 12)
- Concentration of LDL Cholesterol(Baseline and week 12)
- Concentration of HDL Cholesterol(Baseline and week 12)
- Concentration of Triglycerides(Baseline and week 12)
- Concentration of Alanine Aminotransferase (ALT)(Baseline and week 12)
- Concentration of Aspartate Aminotransferase (AST)(Baseline and week 12)
- Concentration of Total Protein(Baseline and week 12)
- Concentration of Albumin(Baseline and week 12)
- Concentration of Complement C3(Baseline and week 12)
- Concentration of Complement C4(Baseline and week 12)
- Presence of Anti-dsDNA(Baseline and week 12)
- Result of Direct Coombs Test(Baseline and week 12)
- Presence of Anti-cardiolipin (ACA) IgG/IgM(Baseline and week 12)
- Presence of Anti-beta-2 glycoprotein I (AB2GP) IgG/IgA/IgM(Baseline and week 12)
- Result of Lupus Anticoagulant (LA)(Baseline and week 12)
- Value of Urine Protein/Creatinine Ratio(Baseline and week 12)
研究者
Sabriye BALLI
Principal Investigator
TC Erciyes University