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NCT07072871: LactoSepsis
Effect of Lactiplantibacillus Plantarum DAD-13 on Inflammatory Markers in ICU Sepsis Patients
NA trial testing Lactiplantibacillus plantarum DAD-13 in Sepsis in 30 participants. Completed in 30 April 2024.
30 April 2024
Quick facts
| Lead sponsor | PT Royal Medikalink Pharmalab |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 April 2024 |
| Primary completion | 30 April 2024 |
| Estimated completion | 30 April 2024 |
| Sites | 1 location across Indonesia |
Drugs / interventions tested
- Lactiplantibacillus plantarum DAD-13
- Placebo
Conditions studied
- Sepsis — all drugs for Sepsis →
- Systemic Inflammatory Response Syndrome (SIRS) — all drugs for Systemic Inflammatory Response Syndrome (SIRS) →
- Critical Illness — all drugs for Critical Illness →
Sponsor
PT Royal Medikalink Pharmalab
Who can join
Adults 18 to 65, any sex, with Sepsis or Systemic Inflammatory Response Syndrome (SIRS). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study investigated whether giving the probiotic Lactiplantibacillus plantarum DAD-13 to sepsis patients in the intensive care unit (ICU) could help reduce inflammation and improve bowel function. A total of 30 adult ICU patients with sepsis were randomly assigned to receive either the probiotic or a placebo for four days, along with standard treatment. Blood tests were performed to measure inflammatory markers, including procalcitonin (PCT), C-reactive protein (CRP), and interleukin-6 (IL-6), before and after the treatment. The study also observed defecation frequency and stool consistency. Results showed a clinical trend toward lower inflammation levels in the probiotic group and significantly better bowel function. The findings suggest that this probiotic may support immune response and gut health in sepsis patients, although more research is needed to confirm these results.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The Effect of Administering the Probiotic Lactiplantibacillus Plantarum DAD-13 on Procalcitonin Levels, C-Reactive Protein, and Interleukin-6 in Sepsis Patients in the Intensive Care Unit of H. Adam Malik Hospital, Medan
Zulkarnain Z, Hanafie A, Lubis AP, Yunanda Y. · · 2025 · DOI 10.21203/rs.3.rs-7174498/v1
Verify or expand the search:
- PubMed search for NCT07072871
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT07072871 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by PT Royal Medikalink Pharmalab
- Last refreshed: 22 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/NCT07072871.
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