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Systemic Lupus ErythematosusNCT07183007

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

A study testing Low gluten diet in people with Systemic Lupus Erythematosus, run by Universitas Indonesia at 1 site in Indonesia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
Low gluten diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteIndonesia
Study dates
21 Sep 2025to Mar 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Indonesia1 site

  • Cipto Mangunkusumo Hospital

    Jakarta Pusat, Jakarta Special Capital Region

    alvina Widhani, Dr. dr, SpPD, KAI, +62213904546, alvina.widhani@gmail.com

    alvina.widhani@gmail.com

Other trials in Indonesia

About this study

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.
Read more

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
Being tested
Low gluten diet
Keywords
systemic lupus erythematosus, dietary intervention, nutrigenomic, HLA-DQ2, HLA-DQ8
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low gluten dietOther

    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

Study groups in NCT07183007
Study groupRoleWhat they receive
Dietary intervention based on genetic dataActive comparatorDietary intervention with low gluten diet for systemic lupus patients with HLA-DQ2 or HLA-DQ8 positive
Receives: Other: Low gluten diet
Control groupNo interventionUsual diet for systemic lupus erythematosus patients with HLA-DQ2 or DQ8 positive

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Systemic Lupus Erythematosus (SLE) Disease Activity

    Measurement of Systemic Lupus Erythematosus disease activity using The Mexican Systemic Lupus Erythematosus Disease Activity Index (MEX SLEDAI). Minimal score is 0 and maximal score is 32. Score 0-1 indicate remission; 2-5 indicate mild disease activity; 6-9 indicate moderate disease activity; 10-13 indicate severe disease activity; and ≥14 indicate very severe disease activity

    Measured: baseline, 1 month after intervention and 3 months after intervention

  2. Lupus Quality of life

    Measurement of the Quality of Life (QOL) of Systemic Lupus Erythematosus patient using the LupusQOL, a disease-specific, 34-item instrument that assesses eight domains: physical health pain, planning, intimate relationship, emotional health, burden to others, body image, and fatigue. Each item uses a 5-point Likert scale (0-4), with domain scores calculated by averaging item responses within each domain, dividing by four, and multiplying by 100 to yield scores ranging from 0 (worst) to 100 (best QoL)

    Measured: baseline, 1 month after intervention and 3 months after intervention

Secondary outcomes (4)

  1. Fatigue score

    Fatigue score is measured using the Fatigue Severity Scale, a 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity according to a self-report scale. The items are scored on a 7-point scale with 1 = strongly disagree and 7= strongly agree.

    The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity.

    Measured: baseline, 1 month after intervention, and 3 months after intervention

  2. Physical activity

    Measuring physical activity using short form of International Physical Activity Questionnaire. This questionnaire provides information on the time spent walking, in vigorous- and moderate intensity activity and in sedentary activity in the last 7 days to estimate total physical activity in MET-min/week and time spent sitting

    Measured: baseline, 1 month after intervention, and 3 months after intervention

  3. Sleep quality

    Measuring sleep quality using Pittsburgh Sleep Quality Index (PSQI). It differentiates "poor" from "good" sleep by measuring seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale.

    A global sum of "5" or greater indicates a "poor" sleeper. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.

    Measured: baseline, 1 month after intervention, and 3 months after intervention

  4. Anxiety and depression

    Measuring anxiety and depression score using Hospital Anxiety Depression Scale (HADS). The HADS is a 14-item questionnaire consists of two subscales: one for anxiety (HADS-A) and one for depression (HADS-D), each containing 7 items. Respondents rate their feelings over the past week on a 4-point Likert scale, where: 0 = Not at all; 1 = Occasionally; 2 = Often; 3 = Most of the time. The total score can range from 0 to 42, combining both anxiety and depression scores. Each subscale (anxiety and depression) can score between 0 and 21.

    Interpretation of Scores: 0-7= Normal; 8-10: Mild symptoms; 11-21: Moderate to severe symptoms.

    Measured: baseline, 1 month after intervention, and 3 months after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2025
  2. Study start21 Sep 2025 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionMar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07183007
Sponsor's protocol ID
KET948/UN2F1/ETIK/PPM0002/2025
Status last verified
Sep 2025
First submitted
28 Aug 2025
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared because it is not included in the informed consent

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.

    PubMed 41290265

Questions about this trial

What is this clinical trial studying?

A study testing Low gluten diet in people with Systemic Lupus Erythematosus, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Systemic Lupus Erythematosus (SLE) Disease Activity (time frame: baseline, 1 month after intervention and 3 months after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07183007, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025; AzTrials last refreshed its copy on 30 Oct 2026.

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