NCT07183007Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 19 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 28 Aug 2025
- Start date
- 21 Sept 2025
- Primary completion date
- Dec 2025
- Lead sponsor
- Universitas Indonesia
- Diseases
- Lupus (SLE)
- NCT number
- NCT07183007
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 21 Sept 2025 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
Lab values
- Patients taking corticosteroids equivalent to more than 20 mg/dL prednisone
Other
- Refusal to participate in the study.
- Pregnancy.
- Breastfeeding.
Who the study is looking for
- Patients with systemic lupus erythematosus (SLE) diagnosed according to the 2019 EULAR/ACR criteria, registered as patients at RSCM.
- Age above 18 years
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cipto Mangunkusumo Hospital Coordinator of this site? Confirm its status | Jakarta Pusat | Indonesia | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.