Probiotics in Systemic Lupus Erythematosus

NCT ID: NCT05433857

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-10
• Study Completion Date: 2024-02-28

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.

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 Blood and urine samples for laboratory investigations will be withdrawn at baseline and at the end of the study.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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

20 patients will receive the standard therapy for 12 weeks

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventional group

20 patients will receive the standard therapy in addition to two capsules once daily of probiotic Lacteol Forte® Capsules for 12 weeks

Group Type: EXPERIMENTAL

Lacteol forte capsules

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

lactobacillus delbruekii and lactobacillus fermentum

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Rana Sayed Fouad

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rana Sayed, PhD

Role: STUDY_DIRECTOR

Faculty of Pharmacy, Ain Shams University

Locations

Ain Shams University Hospitals

Cairo, Abbasseya, Egypt

Countries

Egypt

Other Identifiers

RHDIRB2020110301 REC 80

Identifier Type: -

Identifier Source: org_study_id