Clinical trial NCT05433857: Probiotics in Systemic Lupus Erythematosus
Official title: Evaluation of the Clinical Outcome of Probiotics in Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: Probiotics
Lactobacillus
Systemic lupus erythematosus
SLEDAI-2K
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional, Prospective, randomized, controlled, open-label study.
Primary purpose: TREATMENT

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 Blood and urine samples for laboratory investigations will be withdrawn at baseline and at the end of the study.

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.

Primary outcomes:
measure: Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
timeFrame: At baseline and at 12 weeks
Secondary outcomes:
measure: Improvement of immunologic parameters
timeFrame: At baseline and at 12 weeks
measure: Improvement of serum complement
timeFrame: At baseline and at 12 weeks
measure: patients' quality of life
timeFrame: At baseline and at 12 weeks
measure: Pain assessment
timeFrame: At baseline and at 12 weeks
measure: Incidence of potential adverse effects
timeFrame: Weekly up to 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
state: Abbasseya
Study officials:
affiliation: Faculty of Pharmacy, Ain Shams University
name: Rana Sayed, PhD
role: STUDY_DIRECTOR
References: