Probiotics in Systemic Lupus Erythematosus

Evaluation of the Clinical Outcome of Probiotics in Systemic Lupus Erythematosus

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.

Study Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Drug: Lacteol forte capsules

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 Blood and urine samples for laboratory investigations will be withdrawn at baseline and at the end of the study.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Abbasseya
    • Cairo, Abbasseya, Egypt
      • Ain Shams University hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; 20 patients will receive the standard therapy for 12 weeks
Experimental: Interventional group; 20 patients will receive the standard therapy in addition to two capsules once daily of probiotic Lacteol Forte® Capsules for 12 weeks	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; Other Names: lactobacillus delbruekii and lactobacillus fermentum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)	Change in disease activity measured by SLEDAI-2K score. The most appropriate SLEDAI-2K cut-off score for definition of active disease which links to the need to increase therapy is 3 or 4	At baseline and at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of immunologic parameters	Anti-dsDNA levels	At baseline and at 12 weeks
Improvement of serum complement	Complements 3 and 4	At baseline and at 12 weeks
patients' quality of life	Assessment of patients' quality of life using the validated Arabic Lupus Patient-reported outcome survey version 1.8 (LupusPROv1.8)	At baseline and at 12 weeks
Pain assessment	Pain assessment using the validated Arabic version of the Short-Form McGill Pain Questionnaire	At baseline and at 12 weeks
Incidence of potential adverse effects	Monitoring for side and/or adverse effects	Weekly up to 12 weeks

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Rana Sayed, PhD, Faculty of Pharmacy, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2022
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: June 17, 2022
• First Submitted That Met QC Criteria: June 24, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Estimated): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Probiotics; SLEDAI-2K; Systemic lupus erythematosus; Lactobacillus
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: RHDIRB2020110301 REC 80

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No