Effect of Anti-inflammatory Diet in Systemic Lupus Erythematous

University of California, San Diego36 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Systemic Lupus Erthematosus (SLE)

Interventions

anti-inflammatory dietDIETARY_SUPPLEMENT

anti-inflammatory diet for 6 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Altman Clinical Translational Research Insitute (UC San Diego)

La Jolla, California, United States

RECRUITING

Outcomes

Primary Outcomes

PROMIS pain interference

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.

Time frame: 6 weeks

PROMIS fatigue

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.

Time frame: 6 weeks

Secondary Outcomes

PROMIS physical function

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.

Time frame: 6 weeks

Central Contacts

Monica Guma, MD, PhD

CONTACT

858-822-6523 mguma@health.ucsd.edu

Data from ClinicalTrials.gov

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