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

NCT07072871 | Completed DMC

• 2 other identifiers: 1513/KEPK/USU/2024PT-RMP/2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Lactiplantibacillus plantarum DAD-13; Probiotics; Inflammatory markers; Procalcitonin; C-Reactive Protein; Interleukin-6; Intensive Care Unit Randomized Controlled Trial; Gut microbiota; Immune modulation

Outcome Measures

Primary Outcomes (1)

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

  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.

  Day 1 (T0) to Day 4 (T1) of intervention

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

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.

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

Dietary Supplement: Lactiplantibacillus plantarum DAD-13

EXPERIMENTAL

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.

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

Interventions

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.

Also known as: Probiotic Group, Experimental

Dietary Supplement: Lactiplantibacillus plantarum DAD-13; Placebo Group

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.

Also known as: Control Group

Dietary Supplement: Lactiplantibacillus plantarum DAD-13; Placebo Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• PT Royal Medikalink Pharmalab: lead

Study Sites (1)

H. Adam Malik General Hospital

Medan, Sumatera, 20136, Indonesia

Location

MeSH Terms

Conditions

Sepsis; Systemic Inflammatory Response Syndrome; Critical Illness

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Disease Attributes

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Zulkarnain Zulkarnain, dr.

  H. Adam Malik General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, investigators, and outcomes assessors were all blinded to treatment group assignments throughout the study to prevent bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with two arms: probiotic and placebo.

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 18, 2025
• Study Start: April 1, 2024
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)