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

PT Royal Medikalink Pharmalab

Status: Completed

Conditions: Systemic Inflammatory Response Syndrome (SIRS); Critical Illness; Sepsis

Treatments: Drug: Placebo; Dietary Supplement: Lactiplantibacillus plantarum DAD-13

Study type: Interventional

Funder types: Industry

Identifiers

NCT07072871

PT-RMP/2024 (Other Identifier)

1513/KEPK/USU/2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Placebo Group

Placebo Comparator group

Description:

Participants in this arm received placebo capsules containing maltodextrin via NGT, identical in appearance and schedule to the probiotic group (2 capsules/day for 4 days), alongside standard sepsis care.

Treatment:

Dietary Supplement: Lactiplantibacillus plantarum DAD-13

Drug: Placebo

Dietary Supplement: Lactiplantibacillus plantarum DAD-13

Experimental group

Description:

The probiotic supplement Lactiplantibacillus plantarum DAD-13 was given in capsule form (2 capsules/day) via NGT for 4 days. Each capsule contains a standardized dose of viable bacteria formulated to modulate immune response and gut flora.

Treatment:

Dietary Supplement: Lactiplantibacillus plantarum DAD-13

Drug: Placebo