NCT05433857

Probiotics in Systemic Lupus Erythematosus

Evaluation of the Clinical Outcome of Probiotics in Systemic Lupus Erythematosus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Dysbiosis, or disruption of the gut microbiota, leads to the onset of autoimmunity. Increasing data suggest that the gut microbiota is changed in various murine lupus models as well as in human systemic lupus erythematosus SLE patients. Ingestion of lactobacilli, which have immunoregulatory properties, may be a viable strategy for controlling disease development and progression in patients with lupus, such as increasing the remission period and decreasing flare frequency.

Detailed description

1. Patients will be recruited and evaluated for eligibility. 2. Patients who met the eligibility criteria will be randomly assigned to either control or interventional group. 3. Patients in the control group will receive their standard therapy for 12 weeks and patients in the interventional group will receive their standard therapy plus one sachet daily of lacteol forte sachets for 12 weeks. 4. Collection of demographic data, full medication history, and full medical history will be performed at baseline and every 4 weeks. 5. Assessment of disease activity using SLEDAI-2K score, quality of life using the validated Arabic LupusPROv1.8 questionnaire, and Pain assessment using the validated Arabic version of the Short-Form McGill Pain Questionnaire will be performed at baseline and at the end of the study. 6. Safety and tolerability monitoring will be performed weekly using a side effect and/or adverse effect monitoring sheet. 7. Blood and urine samples for laboratory investigations will be withdrawn at baseline and at the end of the study.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Lacteol forte capsules	probiotic Lacteol Forte® capsules (5 billion heat-killed Lactobacillus LB, corresponding to lactobacillus delbruekii and lactobacillus fermentum) Two capsules are To be taken once daily

Timeline

• Start date: 2022-06-10
• Primary completion: 2023-12-30
• Completion: 2024-02-28
• First posted: 2022-06-27
• Last updated: 2025-11-19

Locations

1 site across 1 country: Egypt