Systemic Lupus Erythematosus
Conditions
Keywords
systemic lupus erythematosus, SLE, synbiotics, disease activity, MEX-SLEDAI, IL-10, TGF-β
Brief summary
Dysregulation of normal flora leads to dysbiosis, which has recently been investigated as an important internal environmental factor and has been proven to be associated with both active and remission phases of SLE, and can be used to predict disease activity. Administration of synbiotics is expected to restore mucosal barrier function and create an anti-inflammatory environment in the gut, by suppressing pro-inflammatory factors and increasing anti-inflammatory factors (IL-10 and TGF-β), leading to improved disease activity in SLE patients.
Detailed description
This research is a double blind randomized controlled trial study. The study subjects were 36 patients diagnosed with mild to moderate lupus activity, randomly divided into 2 groups, who received synbiotic supplementation once daily for 12 weeks and the group that received placebo. Serum IL-10 and TGF-β levels and the degree of disease activity using MEX-SLEDAI score were measured before and after treatment.
Interventions
DIETARY_SUPPLEMENTSynbiotic
The patients received synbiotics (containing Lactobacillus helveticus R0052 60%, Bifidobacterium infantis R0033 20%, Bifidobacterium bifidum R0071 20% and frukto-oligosaccharide 80 mg) supplementation
DIETARY_SUPPLEMENTPlacebo
Patients received placebo capsules
Sponsors
Universitas Sriwijaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Triple (Participant, Care Provider, Investigator)
Intervention model description
This research is a double blind randomized controlled trial study. The study subjects were 36 patients diagnosed with mild to moderate lupus activity, randomly divided into 2 groups, who received synbiotic supplementation once daily for 12 weeks and the group that received placebo. Serum IL-10, TGF-β levels and the degree of disease activity using MEX-SLEDAI score were measured before and after treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. All patients diagnosed with mild to moderate Systemic Lupus Erythematosus (SLE). 2. Patients aged over 18 years. 3. Willing to participate in the study by signing an informed consent form. 4. Have not consumed yogurt or supplements containing probiotics, prebiotics, or synbiotics within the last 2 weeks.
Exclusion criteria
1\. Severe SLE. 2, Pregnant or breastfeeding. 3. History of allergy to probiotics or prebiotics. 4. Patients with other immune-related disorders, whether autoimmune or immunocompromised conditions such as HIV or rheumatoid arthritis. 5\. SLE with pulmonary tuberculosis. 6. Currently undergoing antibiotic therapy. 7. SLE with malignancy. Drop-Out Criteria 1. Patients discontinue synbiotic intake for more than 2 weeks. 2. Death. 3. Occurrence of serious adverse drug reactions requiring discontinuation of the study drug. 4. Patients consume yogurt or supplements containing probiotics/synbiotics more than once per week outside of the study intervention, or undergo changes in steroid-sparing agents during the study period. 5. Patients require hospitalization due to symptom exacerbation during the intervention period. 6. Loss to follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IL-10 | From enrollment to the end of the treatment at 12 weeks | To determine the effectiveness of adding synbiotics compared to placebo on IL-10 concentration change in Systemic Lupus Erythematosus Patients |
| TGF-B | From enrollment to the end of the treatment at 12 weeks | To determine the effectiveness of adding synbiotics compared to placebo on TGF-B concentration change in Systemic Lupus Erythematosus Patients |
| MEX-SLEDAI score | From enrollment to the end of the treatment at 12 weeks | To determine the effectiveness of adding synbiotics compared to placebo towards MEX-SLEDAI score changes |
Countries
Indonesia
Outcome results
None listed