Development of a Dietary Intervention Model Based on Genetic Data as an Implementation of a Healthy Lifestyle in the Management of Systemic Lupus Erythematosus Patients

Обзор

The goal of this clinical trial is to learn if dietary intervention based on genetic data benefits in the management of systemic lupus erythematosus patients. It will also learn about the safety of this intervention. The main questions it aims to answer are: * What is the effect of dietary intervention based on genetic data as part of a healthy lifestyle in the management of SLE patients on disease activity? * What is the effect of dietary intervention based on genetic data as part of a healthy lifestyle in the management of SLE patients on quality of life Researchers would compare dietary intervention based on genetic data to a no intervention to see if dietary intervention based on genetic data improves disease activity and quality of life of SLE patients. Participants will: * Be checked for genetic test (HLA DQ2 and DQ8) as screening * Be randomized to dietary intervention group or control group if has HLA DQ2 or DQ8 positive from screening * Visit the clinic once every month for checkups and lab test if were randomized to dietary intervention group or control group * Do food record as instructed if were randomized to dietary intervention group or control group

Вмешательства

• Другое Low gluten diet
  Systemic lupus erythematosus patients with HLA-DQ2 or DQ-8 positive will be randomized to dietary intervention group or control group. Those who are randomized to dietary intervention group will get dietary planning and intervention from a nutritionist with low gluten diet

Первичные конечные точки

• Systemic Lupus Erythematosus (SLE) Disease Activity [Срок оценки: baseline, 1 month after intervention and 3 months after intervention]
• Lupus Quality of life [Срок оценки: baseline, 1 month after intervention and 3 months after intervention]

Вторичные конечные точки (4)

• Fatigue score [Срок оценки: baseline, 1 month after intervention, and 3 months after intervention]
• Physical activity [Срок оценки: baseline, 1 month after intervention, and 3 months after intervention]
• Sleep quality [Срок оценки: baseline, 1 month after intervention, and 3 months after intervention]
• Anxiety and depression [Срок оценки: baseline, 1 month after intervention, and 3 months after intervention]

Критерии участия

Критерии включения

• Patients with systemic lupus erythematosus (SLE) diagnosed according to the 2019 EULAR/ACR criteria, registered as patients at RSCM.
• Age above 18 years

Критерии исключения

• Presence of active infection.
• Refusal to participate in the study.
• Pregnancy.
• Breastfeeding.
• Already on a specific autoimmune-related diet.
• Patients with severe medical conditions (active cancer, stage V chronic kidney disease, or acute heart failure).
• Patients taking corticosteroids equivalent to more than 20 mg/dL prednisone

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Индонезия · 1 центр

• Cipto Mangunkusumo Hospital — Jakarta Pusat

Публикации

• Widhani A, Wardhani WI, Shahab SN, Kasih M, Cahyanur R, Yunihastuti E, Ahani AR. Dietary Intervention for Systemic Lupus Erythematosus patients based on HLA-DQ2 and DQ8 genotyping (DISH): a protocol for a randomised controlled study. Lupus Sci Med. 2025 Nov 24;12(2):e001833. doi: 10.1136/lupus-2025-001833. PMID 41290265

Идентификаторы

NCT: NCT07183007 · KET948/UN2F1/ETIK/PPM0002/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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