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

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.

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Key information

Conditions

Sepsis Critical Illness Disease Attributes Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Systemic Inflammatory Response Syndrome Systemic Inflammatory Response Syndrome (SIRS)

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

H. Adam Malik General Hospital

Medan, Sumatera, 20136, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 18-65 years.
Diagnosed with sepsis based on clinical and laboratory criteria.
Admitted to ICU.
Receiving enteral nutrition (1500-2000 kcal/day) via nasogastric tube.
Able to provide or have proxy informed consent.

Exclusion criteria

History of gastrointestinal disease.
Immunocompromised condition (e.g., HIV, chemotherapy).
Presence of intravascular devices.
Known allergy to probiotics.
Concurrent participation in other clinical trials

Treatment and study plan

Lactiplantibacillus plantarum DAD-13

Dietary Supplement

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.

Other names: Probiotic Group, Experimental

Placebo

Drug

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.

Other names: Control Group

Primary outcomes

Change in Procalcitonin (PCT) levels in ICU sepsis patients after probiotic administration

Time frame: Day 1 (T0) to Day 4 (T1) of intervention

This outcome assesses the change in Procalcitonin (PCT) levels from baseline (day 1) to day 4 in patients with sepsis who receive Lactiplantibacillus plantarum DAD-13 or placebo. PCT is a biomarker used to evaluate the severity of systemic inflammation and response to treatment in sepsis.

Sponsors and collaborators

Lead sponsor

PT Royal Medikalink Pharmalab

Industry

Registry information

Official study title

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

Acronym: LactoSepsis

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Jul 18, 2025
Registry last updated: Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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