Probiotics in Systemic Lupus Erythematosus

NCT05433857 | Completed Phase 2

• 1 other identifier: RHDIRB2020110301 REC 80
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Systemic Lupus Erythematosus

Keywords

Probiotics; Lactobacillus; Systemic lupus erythematosus; SLEDAI-2K

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Improvement of immunologic parameters

  At baseline and at 12 weeks

• Improvement of serum complement

  At baseline and at 12 weeks

• patients' quality of life

  At baseline and at 12 weeks

• Pain assessment

  At baseline and at 12 weeks

• Incidence of potential adverse effects

  Weekly up to 12 weeks

Study Arms (2)

Control group

NO INTERVENTION

20 patients will receive the standard therapy for 12 weeks

Interventional group

EXPERIMENTAL

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

Interventions

Lacteol forte capsules DRUG

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

Also known as: lactobacillus delbruekii and lactobacillus fermentum

Interventional group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Abbasseya, Egypt

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Rana Sayed, PhD

  Faculty of Pharmacy, Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Interventional, Prospective, randomized, controlled, open-label study.

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 27, 2022
• Study Start: June 10, 2022
• Primary Completion: December 30, 2023
• Study Completion: February 28, 2024
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)