Mediterranean Diet and Gut Microbiota in Children With Systemic Lupus Erythematosus

Official title

Effects of a Mediterranean Diet-Based Nutritional Intervention on Gut Microbiota, Disease Activity, and Nutritional Status in Children With Systemic Lupus Erythematosus

Overview

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.

Interventions

• Behavioral Mediterranean Diet-Based Individual Nutrition Counseling
  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 p

Primary outcome measures

• Gut microbiota diversity [Time frame: Baseline (Week 0) and Week 12]
• Change in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score [Time frame: Baseline and week 12]

Secondary outcome measures (12)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Erciyes University Mustafa Eraslan and Fevzi Mercan Children's Hospital — Kayseri

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. PMID 19864399
• Ravelli 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. PMID 12910556
• Stoll 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. PMID 8620300
• Stoll 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. PMID 15161983
• Urowitz 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. PMID 9890104
• Eder 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. PMID 24097994
• Gladman 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 lupu PMID 8607884
• Gladman DD, Ibanez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002 Feb;29(2):288-91. PMID 11838846

Identifiers

NCT: NCT07555626 · TDK-2026-15829

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗