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
Phase: NA
Conditions: Sepsis, Systemic Inflammatory Response Syndrome (SIRS), Critical Illness
Sponsor: PT Royal Medikalink Pharmalab

The Effect of Administering the Probiotic Lactiplantibacillus 
Plantarum DAD-13 on Procalcitonin Levels, C-Reactive Protein, and 
Interleukin-6 in Sepsis Patients in the ICU of H. Adam Malik 
Hospital, Medan 
 
 
NCT Number: Pending 
Document Date: July 9, 2025 
Study Protocol 
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 ICU of H. 
Adam Malik Hospital, Medan 
NCT Number: Pending 
Document Date: July 9, 2025 
Background and Rationale: Sepsis is a life-threatening organ dysfunction caused by a 
dysregulated host response to infection. Dysbiosis and disruption of intestinal barrier 
function are critical components of sepsis pathophysiology. Probiotics may modulate 
inflammatory responses and restore gut microbiota balance. L. plantarum DAD-13, an 
Indonesian probiotic strain, has demonstrated immunomodulatory potential in preclinical 
studies. This study aims to evaluate the effect of L. plantarum DAD-13 on inflammatory 
markers and gastrointestinal outcomes in ICU patients with sepsis. 
Study Objectives: Primary Objective: 
• 
To assess the effect of L. plantarum DAD-13 on Procalcitonin (PCT), C-Reactive 
Protein (CRP), and Interleukin-6 (IL-6) levels. 
Secondary Objective: 
• 
To assess changes in defecation frequency and stool consistency. 
Study Design: 
• 
Type: Prospective, randomized, double-blind, placebo-controlled trial 
• 
Sample size: 30 patients (15 per group) 
• 
Duration: 4-day intervention period 

Eligibility Criteria: Inclusion: 
• 
Age 18–65 years 
• 
Diagnosed with sepsis 
• 
Admitted to ICU 
• 
Receiving enteral nutrition 
Exclusion: 
• 
Known gastrointestinal disease 
• 
Immunocompromised status 
• 
Probiotic allergy 
• 
Use of other probiotic products 
Intervention: 
• 
Experimental Group: 2 capsules/day of L. plantarum DAD-13 (Vipilac®) 
• 
Control Group: 2 capsules/day of placebo (maltodextrin) 
• 
Duration: 4 days 
Endpoints: 
• 
Primary: Change in serum PCT, CRP, and IL-6 from baseline to day 4 
• 
Secondary: Frequency and consistency of defecation 
Data Collection and Monitoring: 
• 
Biomarkers (PCT, CRP, IL-6) measured at T0 (day 1) and T1 (day 4) 
• 
Stool data collected daily 
• 
Double-blind protocol maintained throughout study 
Ethics: Approved by the Health Research Ethics Committee of Universitas Sumatera Utara. 
Informed consent obtained from all participants or legal representatives. 
 
Statistical Analysis Plan (SAP) 
Study Population: 

• 
Intent-to-Treat (ITT): All randomized participants 
• 
Per-Protocol (PP): Participants who completed the 4-day intervention 
Descriptive Analysis: 
• 
Means and standard deviations (SD) for continuous variables 
• 
Frequencies and percentages for categorical variables 
Comparative Analysis: 
• 
Within-group (T0 vs T1): Wilcoxon Signed Rank Test (non-parametric) 
• 
Between-group: Mann-Whitney U Test for biomarkers, Chi-square for defecation 
frequency/consistency 
• 
Significance level: p < 0.05 
Missing Data: 
• 
Data imputed using last observation carried forward (LOCF) method for missing T1 
values 
 
Informed Consent Form (ICF) 
Study Title: The Effect of Administering the Probiotic Lactiplantibacillus plantarum DAD-13 
on PCT, CRP, and IL-6 in Sepsis Patients 
Investigator: Andriamuri Primaputra Lubis, MD Institution: H. Adam Malik Hospital, 
Universitas Sumatera Utara Contact: andriamuri@usu.ac.id, 08126078194 
Purpose: You are invited to participate in a clinical study evaluating the effects of a probiotic 
on inflammation and gut function in sepsis patients. Participation is voluntary. 
Procedures: 
• 
You will receive either probiotic capsules or placebo for 4 days 
• 
Blood samples will be taken twice (day 1 and day 4) 
• 
Stool consistency and frequency will be recorded 
Risks and Benefits: 
• 
Risks: Mild gastrointestinal discomfort, rare allergic reaction 
• 
Benefits: Possible improvement in inflammation and gut function 

Confidentiality: All data will be anonymized. Your name will not appear in any publication. 
Voluntary Participation: You may withdraw from the study at any time without affecting 
your medical care. 
Consent: By signing this form, you agree to participate in this study. 
Participant Name: _____________________ Date: ______________ Signature: ____________________________ 
Witness Name: ________________________ Signature: ____________________________