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Not yet recruiting NCT07183007

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

No phase Interventional Systemic Lupus Erythematosus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low gluten diet.
Who it may be relevant to
Registry conditions: Systemic Lupus Erythematosus. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Indonesia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Other 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

Primary outcome measures

  • Systemic Lupus Erythematosus (SLE) Disease Activity [Time frame: baseline, 1 month after intervention and 3 months after intervention]
  • Lupus Quality of life [Time frame: baseline, 1 month after intervention and 3 months after intervention]
Secondary outcome measures (4)
  • Fatigue score [Time frame: baseline, 1 month after intervention, and 3 months after intervention]
  • Physical activity [Time frame: baseline, 1 month after intervention, and 3 months after intervention]
  • Sleep quality [Time frame: baseline, 1 month after intervention, and 3 months after intervention]
  • Anxiety and depression [Time frame: baseline, 1 month after intervention, and 3 months after intervention]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Indonesia · 1 center
  • Cipto Mangunkusumo Hospital — Jakarta Pusat

Publications

  • 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

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗