Using probiotics to treat systemic lupus erythematosus

Evaluation of the Clinical Outcome of Probiotics in Systemic Lupus Erythematosus

This study is testing if adding lactobacilli probiotics to standard treatment can help people with systemic lupus erythematosus feel better and improve their quality of life.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Ain Shams University (Academic / other)
• Locations: 1 site (Cairo, Abbasseya)
• Trial ID: NCT05433857 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of lactobacilli probiotics on patients with systemic lupus erythematosus (SLE). Eligible participants, aged 18-65, will be randomly assigned to receive either standard therapy alone or standard therapy plus daily lacteol forte sachets for 12 weeks. The study will assess disease activity, quality of life, and pain levels using validated questionnaires and scores at baseline and after the intervention. Safety and tolerability will be monitored weekly, with blood and urine samples collected for laboratory analysis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 diagnosed with active systemic lupus erythematosus.

Not a fit: Patients with severe neuropsychiatric manifestations of SLE or those with other autoimmune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve disease management and quality of life for patients with systemic lupus erythematosus.

How similar studies have performed: While the use of probiotics in autoimmune conditions is being explored, this specific approach in systemic lupus erythematosus is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Age 18-65 years, male or female.
2. Patients are willing to sign a written informed consent.
3. Patients fulfilling American college of rheumatology classification criteria for SLE.
4. Patients diagnosed with active systemic lupus erythematosus defined as SLEDAI-2K score more than 4.

Exclusion Criteria:

1. Patients ˂ 18 years or ˃65 years of age.
2. Patients with a history of drug allergies to probiotics administration.
3. Pregnant or breastfeeding females.
4. Current probiotics use.
5. Patients scheduled for surgical intervention during the study period or up to 2 weeks after the end of the study.
6. patients suffering from active severe neuropsychiatric manifestations of SLE.
7. Patients with other auto-immune diseases.
8. Patients suffering from any type of cancer.
9. patients participating in other clinical trials.

Where this trial is running

Cairo, Abbasseya

• Ain Shams University Hospitals — Cairo, Abbasseya, Egypt (Recruiting)

Study contacts

• Study coordinator: Hend Mahran, BSc

Conditions Systemic Lupus Erythematosus; Probiotics; Lactobacillus; Systemic lupus erythematosus; SLEDAI-2K