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NCT Number: NCT07713940

Effect of Anti-inflammatory Diet in Systemic Lupus Erythematous

To study the effect of anti-inflammatory diet on clinical and biological outcomes in lupus

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Key information

Conditions

Systemic Lupus Erthematosus (SLE)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Altman Clinical Translational Research Insitute (UC San Diego)

La Jolla, California, 92097, United States

Location status: Recruiting

Location contact

Monica Guma, MD, PhD

CONTACT

[email protected]

858-

Monica Guma, MD.PhD

PRINCIPAL_INVESTIGATOR

About this study

The investigators aim to evaluate how inflammation changes in individuals with lupus and to identify molecules and gut bacteria that may help predict disease flares. Blood and stool samples will be analyzed in the laboratory and compared with samples collected from the same participants following dietary changes.

This is an exploratory study designed to generate preliminary data on the short-term effects of dietary changes and treatment on blood biomarkers and the gut microbiome. The findings may provide insights into the mechanisms underlying lupus and could ultimately contribute to the development of new therapeutic approaches.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients who meet the 2019 EULAR/ACR Classification Criteria for SLE
  • patients who are on Cellcept or Myfortic for at least 3 months prior to screening
  • patients with a score of ≥55 on the Patient Reported Outcomes Measurement Information System (PROMIS) Pain interference scale.

Exclusion criteria

  • pregnant or lactating patients,
  • patients with food allergy
  • patients on antibiotics within 4 weeks of the screening
  • patients that change the SLE therapy during the length of the study (12 weeks).

Treatment and study plan

Anti-inflammatory diet

Dietary Supplement

anti-inflammatory diet for 6 weeks

Primary outcomes

  1. PROMIS pain interference

    Time frame: 6 weeks

    PROMIS Pain Interference: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference. Scores are typically reported as T-scores ranging from approximately 20 to 80 (theoretical range varies by item bank). Higher scores indicate worse outcomes, reflecting greater pain interference with daily activities.

  2. PROMIS fatigue

    Time frame: 6 weeks

    PROMIS Fatigue: Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue. Scores are typically reported as T-scores ranging from approximately 20 to 80. Higher scores indicate worse outcomes, reflecting greater fatigue.

Secondary outcomes

  1. PROMIS physical function

    Time frame: 6 weeks

    PROMIS Physical Function: Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function. Scores are typically reported as T-scores ranging from approximately 20 to 80. Higher scores indicate better outcomes, reflecting better physical functioning.

Study contacts

Contact information is provided by the study sponsor or research team.

Monica Guma, MD, PhD

CONTACT

[email protected]

858-822-6523

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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