Effect of Anti-inflammatory Diet in Systemic Lupus Erythematous
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- PROMIS pain interference
Study Overview
Brief Summary
To study the effect of anti-inflammatory diet on clinical and biological outcomes in lupus
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Outcomes
Primary Outcomes
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.
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
- PROMIS physical function(6 weeks)
Investigators
Monica Guma
Professor
University of California, San Diego