Testing a gene-guided diet for people with systemic lupus erythematosus
Tests a diet chosen from genetic results in adults with systemic lupus erythematosus.
Key facts
- Who runs it
- Universitas Indonesia
- Where
- Jakarta Pusat, IndonesiaSee the site
- Trial code
- Registry title
- 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
- Status
- Not yet recruiting
- People taking part
- 100 people, planned
- Started
- 21 Sept 2025
- Planned end
- Mar 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Low gluten diet
- Record updated
- 19 September 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with systemic lupus erythematosus (SLE). They are first tested for the HLA DQ2 and DQ8 genes. Those who test positive are then placed at random into a diet group or a no-intervention group.
- Age
- Above 18 years
- Sex
- All sexes can join.
- Disease stage
- SLE diagnosed by the 2019 EULAR/ACR criteria, registered as a patient at RSCM.
- Earlier treatment
- Cannot be on a specific autoimmune-related diet. Cannot take corticosteroids at more than the equivalent of 20 mg/dL prednisone.
- Biomarker or test result
- HLA DQ2 or DQ8 positive on the screening genetic test, to be placed in the diet or control group.
Main reasons for not taking part
- Active infection
- Pregnancy
- Breastfeeding
- Severe medical conditions (active cancer, stage V chronic kidney disease, or acute heart failure)
- Refusal to take part in the study
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- Patients with systemic lupus erythematosus (SLE) diagnosed according to the 2019 EULAR/ACR criteria, registered as patients at RSCM
- Age above 18 years
Who cannot take part
- Presence of active infection
- 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
- Refusal to participate in the study
- Pregnancy
- Breastfeeding
Where in Indonesia
- Cipto Mangunkusumo HospitalJakarta Pusat, IndonesiaContact: alvina Widhani, Dr. dr, SpPD, KAINo longer taking part
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
* 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
The 2 groups in the trial
- Dietary intervention based on genetic dataExisting treatment, for comparison
Dietary intervention with low gluten diet for systemic lupus patients with HLA-DQ2 or HLA-DQ8 positive
Treatment: Low gluten diet
- Control groupNo study treatment, for comparison
Usual diet for systemic lupus erythematosus patients with HLA-DQ2 or DQ8 positive
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Testing a gene-guided diet for people with systemic lupus erythematosusGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Publications
- Record updated
- 19 September 2025