NCT07072871

Effect of Lactiplantibacillus Plantarum DAD-13 on Inflammatory Markers in ICU Sepsis Patients

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: PT Royal Medikalink Pharmalab · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This randomized controlled trial aimed to evaluate the potential benefits of the probiotic Lactiplantibacillus plantarum DAD-13 in adult ICU patients diagnosed with sepsis. The primary objective was to assess the probiotic's effect on systemic inflammation and gastrointestinal function. A total of 30 patients were randomly divided into two groups: one group received the probiotic preparation for four days in addition to standard sepsis management, while the other group received a placebo with the same treatment duration. Inflammatory biomarkers such as procalcitonin (PCT), C-reactive protein (CRP), and interleukin-6 (IL-6) were measured before and after the intervention to evaluate immune and inflammatory responses. In addition, clinical observations were conducted on bowel movement frequency and stool consistency to assess bowel function. The results indicated a trend toward reduced levels of inflammatory markers in the probiotic group compared to the placebo group. Moreover, patients who received the probiotic exhibited improved bowel function, including more regular defecation and better stool consistency. These findings support the hypothesis that Lactiplantibacillus plantarum DAD-13 may contribute to reducing inflammation and enhancing gut health in critically ill sepsis patients. However, due to the limited sample size, further studies are warranted to confirm the clinical significance and safety of this intervention in broader patient populations.

Conditions

• Sepsis
• Systemic Inflammatory Response Syndrome (SIRS)
• Critical Illness

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactiplantibacillus plantarum DAD-13	A probiotic supplement (Vipilac®) containing Lactiplantibacillus plantarum DAD-13 administered orally via nasogastric tube, 2 capsules daily for 4 days, intended to modulate immune response and support gut microbiota in ICU sepsis patients.
DRUG	Placebo	Placebo capsules containing maltodextrin administered via nasogastric tube (NGT), identical in appearance and schedule to the probiotic group (2 capsules/day for 4 days), alongside standard sepsis care.

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2025-07-18
• Last updated: 2025-07-22

Locations

1 site across 1 country: Indonesia