Trials / Completed
CompletedNCT07048470
Efficacy of Synbiotic Supplementation on IL-10, TGF-B and Disease Activity in Systemic Lupus Erythematosus Patients
Efficacy of Synbiotic Supplementation on IL-10, TGF-B and Disease Activity in Systemic Lupus Erythematosus Patients; A Randomized, Double-Blind, Placebo-Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Universitas Sriwijaya · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Synbiotic | The patients received synbiotics (containing Lactobacillus helveticus R0052 60%, Bifidobacterium infantis R0033 20%, Bifidobacterium bifidum R0071 20% and frukto-oligosaccharide 80 mg) supplementation |
| DIETARY_SUPPLEMENT | Placebo | Patients received placebo capsules |
Timeline
- Start date
- 2023-12-01
- Primary completion
- 2024-03-01
- Completion
- 2024-03-01
- First posted
- 2025-07-02
- Last updated
- 2025-07-02
Locations
1 site across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT07048470. Inclusion in this directory is not an endorsement.