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NCT07048470: ESSENTIAL
Efficacy of Synbiotic Supplementation on IL-10, TGF-B and Disease Activity in Systemic Lupus Erythematosus Patients
NA trial testing Synbiotic in Systemic Lupus Erythematosus in 36 participants. Completed in 1 March 2024.
1 March 2024
Quick facts
| Lead sponsor | Universitas Sriwijaya |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 1 December 2023 |
| Primary completion | 1 March 2024 |
| Estimated completion | 1 March 2024 |
| Sites | 1 location across Indonesia |
Drugs / interventions tested
- Synbiotic — full drug profile →
- Placebo
Conditions studied
- Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →
Sponsor
Universitas Sriwijaya — full company profile →
Who can join
18 and older, any sex, with Systemic Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07048470
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Synbiotic
Trials testing the same drug.
- NCT07515443 — The Effects of a Commercially Available Synbiotic on the Gut Microbiome and Cardiometabolic Health: A Randomized Double- · NA · completed
- NCT06901739 — Therapeutic Potential of a Synbiotic to Improve Mental Health in Subjects With Obesity. · NA · recruiting
- NCT06396689 — NapBiome: Targeting Gut Microbiota and Sleep Rhythm to Improve Developmental and Behavioral Outcomes in Early Childhood · NA · not yet recruiting
- NCT06300060 — Synbiotic Supplementation in Cyclists · NA · completed
- NCT06722443 — Impact of Nutritional Intervention With Probiotics and Prebiotics on Obesity. · NA · enrolling by invitation
Other recruiting trials for Systemic Lupus Erythematosus
Currently open trials in the same condition.
- NCT06984341 — A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in P · Phase 1 · recruiting
- NCT07526350 — MTS109 in Patients With Refractory Autoimmune Diseases · EARLY_PHASE1 · recruiting
- NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
- NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting
- NCT07371468 — A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD) · Phase 1 · recruiting
Other Universitas Sriwijaya trials
Trials by the same sponsor.
- NCT07337863 — A Phase II/III Randomized Double-Blind Multicenter Study Comparing UC-MSC-Derived Secretome and Sodium Hyaluronate in Pa · Phase 2, PHASE3 · not yet recruiting
- NCT07089329 — Efficacy of Striatin in Malnourished Children · Phase 3 · recruiting
- NCT07586579 — Aerobic Exercise and Body Composition in Overweight and Obese Boys. · NA · completed
- NCT07071220 — Efficacy of Vitamin C Supplementation on Serum IL-6 Levels and Disease Activity in Systemic Lupus Erythematosus Patients · NA · completed
- NCT07083622 — Efficacy of Vitamin C Supplementation on Malondialdehid Levels and Disease Activity in SLE Patients · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07048470 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universitas Sriwijaya
- Last refreshed: 2 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07048470.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing