Dietary Intervention for Systemic Lupus Erythematosus patients based on HLA-DQ2 and DQ8 genotyping (DISH): a protocol...

SLE is a chronic autoimmune disease that is influenced by both genetic and environmental factors, one of which is diet. Dietary intervention plays a role in the management of SLE, and precision nutrition based on genetic data may enhance its effectiveness. The human leukocyte antigen (HLA)-DQ2 and DQ8 genotypes are strongly associated with coeliac disease (CD), and emerging evidence suggests a possible link between SLE and CD. However, no published studies have explored the use of HLA-DQ2 and DQ8 genotyping to guide dietary intervention in patients with SLE. This study aims to investigate the impact of dietary intervention, tailored to HLA-DQ2 and DQ8 genotyping, on disease activity and quality of life of patients with SLE.

90 patients with SLE with positive HLA-DQ2 or DQ8 genotyping will be randomised in a 1:1 ratio to either the intervention group or a control group. Participants in the intervention group will receive intervention in the form of a low-gluten dietary modification for 12 weeks. Participants in both groups will continue their usual SLE medications. During three research visits (weeks 0, 4 and 12), all participants will complete a clinical interview, blood sample collection, dietary assessment and a questionnaire. Disease activity and quality of life will be assessed by the Mexican Systemic Lupus Erythematosus Disease Activity Index score and Lupus Quality of Life questionnaire. Other secondary outcomes that will also be assessed are fatigue score, sleep quality, anxiety and depression, and physical activity.

This study has obtained ethical approval from the Ethics Committee of the Faculty of Medicine, University of Indonesia-Cipto Mangunkusumo Hospital (KET948/UN2F1/ETIK/PPM0002/2025). Findings will be published in peer-reviewed journals and submitted for intellectual property rights.

NCT07183007.