Efficacy of Synbiotic Supplementation on IL-10, TGF-B and Disease Activity in Systemic Lupus Erythematosus Patients

Not Applicable

Completed

• Conditions: Systemic Lupus Erythematosus

• Registration Number: NCT07048470
• Lead Sponsor: Universitas Sriwijaya

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.

Study Timeline

• Study Start: 2023-12-01
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-01
• Status Verified: 2025-06
• Study First Submitted: 2025-06-20
• Study First Submitted QC: 2025-06-30
• Last Update Submitted: 2025-06-30
• Study First Posted: 2025-07-02
• Last Update Posted: 2025-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Mohammad Hoesin General Hospital; 🇮🇩 Palembang, South Sumatera, Indonesia