Probiotics in Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

Official title:

Evaluation of the Clinical Outcome of Probiotics in Systemic Lupus Erythematosus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05433857
• Other study ID #: RHDIRB2020110301 REC 80
• Status: Recruiting
• Phase: Phase 2
• Start date: June 10, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: July 2023
• Source: Ain Shams University
• Contact: Hend Mahran, BSc
• Phone: +201157884145
• Email: hend.mohran[@]pharma.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 Blood and urine samples for laboratory investigations will be withdrawn at baseline and at the end of the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospitals	Cairo	Abbasseya

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Improvement of immunologic parameters	Anti-dsDNA levels	At baseline and at 12 weeks
Secondary	Improvement of serum complement	Complements 3 and 4	At baseline and at 12 weeks
Secondary	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
Secondary	Pain assessment	Pain assessment using the validated Arabic version of the Short-Form McGill Pain Questionnaire	At baseline and at 12 weeks
Secondary	Incidence of potential adverse effects	Monitoring for side and/or adverse effects	Weekly up to 12 weeks