SepsisLactoSepsisNCT07072871
Effect of Lactiplantibacillus Plantarum DAD-13 on Inflammatory Markers in ICU Sepsis Patients
A study testing Lactiplantibacillus plantarum DAD-13 in people with Sepsis and Systemic Inflammatory Response Syndrome (SIRS), run by PT Royal Medikalink Pharmalab at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sepsis, Systemic Inflammatory Response Syndrome (SIRS), Critical Illness
- What is being tested?
- Lactiplantibacillus plantarum DAD-13
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteIndonesia
- Study dates
- 19 Feb 2025to 10 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years.
- New diagnosis of sepsis (suspected infection with an acute increase in SOFA score of 2 points or more) in a patient admitted to the intensive care unit.
- Nasogastric tube in place, receiving a single standard enteral formula of 1500-2000 kcal per day.
- Written informed consent from the patient or legally authorized representative.
Who cannot join
- Pregnancy or breastfeeding.
- Sepsis originating from a gastrointestinal infection.
- Gastrointestinal surgery within the previous year.
- Gastrostomy, jejunostomy or colostomy.
- History of gastrointestinal disease (inflammatory bowel disease, Crohn's disease, lactose intolerance, colitis, diverticulitis).
- Active gastrointestinal symptoms (melena, hematochezia, diarrhea, steatorrhea, vomiting, abdominal distension).
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- Immunocompromised state (autoimmune disease, HIV/AIDS, malignancy, chemotherapy, organ transplantation).
- Endovascular risk factors (rheumatic or congenital heart disease, prosthetic heart valve, endocarditis, endovascular grafts or devices).
- Acute pancreatitis.
- Any nutrition other than the single enteral formula via nasogastric tube.
- Known allergy to any component of the study product.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Being tested
- Lactiplantibacillus plantarum DAD-13, Placebo
- Keywords
- Lactiplantibacillus plantarum DAD-13, Probiotics, Inflammatory markers, Procalcitonin, C-Reactive Protein, Interleukin-6, Intensive Care Unit Randomized Controlled Trial, Gut microbiota, Immune modulation
- Medical subject headings
- Sepsis, Systemic Inflammatory Response Syndrome, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactiplantibacillus plantarum DAD-13Dietary supplement
Also called Probiotic Group, Experimental
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.
PlaceboDrug
Also called Control Group
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Lactiplantibacillus plantarum DAD-13; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 (T0) to Day 4 (T1) of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start19 Feb 2025
- Primary completion10 Mar 2025
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with two arms: probiotic and placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Royal Medikalink Pharmalab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zulkarnain Zulkarnain, dr., Principal investigator, H. Adam Malik General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072871
- Sponsor's protocol ID
- 1513/KEPK/USU/2024
- Other IDs
- PT-RMP/2024
- Acronym
- LactoSepsis
- Status last verified
- Oct 2026
- First submitted
- 29 Jun 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07072871
- Acronym / sponsor ID
- LactoSepsis / 1513/KEPK/USU/2024
- Keywords
- Lactiplantibacillus plantarum DAD-13, Probiotics, Inflammatory markers, Procalcitonin, C-Reactive Protein, Interleukin-6, Intensive Care Unit Randomized Controlled Trial, Gut microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- PT Royal Medikalink PharmalabIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 18 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with two arms: probiotic and placebo.
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Dietary Supplement: Lactiplantibacillus plantarum DAD-13, Drug: PlaceboParticipants 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 | Experimental | Dietary Supplement: Lactiplantibacillus plantarum DAD-13, Drug: PlaceboThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 65 years.
- New diagnosis of sepsis (suspected infection with an acute increase in SOFA score of 2 points or more) in a patient admitted to the intensive care unit.
- Nasogastric tube in place, receiving a single standard enteral formula of 1500-2000 kcal per day.
- Written informed consent from the patient or legally authorized representative.
Key exclusion criteria (11 listed)
- Pregnancy or breastfeeding.
- Sepsis originating from a gastrointestinal infection.
- Gastrointestinal surgery within the previous year.
- Gastrostomy, jejunostomy or colostomy.
- History of gastrointestinal disease (inflammatory bowel disease, Crohn's disease, lactose intolerance, colitis, diverticulitis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactiplantibacillus plantarum DAD-13Also: Probiotic Group, ExperimentalA 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. | Dietary supplement | Dietary Supplement: Lactiplantibacillus plantarum DAD-13, Placebo Group |
| PlaceboAlso: Control GroupPlacebo 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. | Drug | Dietary Supplement: Lactiplantibacillus plantarum DAD-13, Placebo Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zulkarnain Zulkarnain, dr. principal investigator
H. Adam Malik General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactiplantibacillus plantarum DAD-13 in people with Sepsis and Systemic Inflammatory Response Syndrome (SIRS), run by PT Royal Medikalink Pharmalab at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Procalcitonin (PCT) levels in ICU sepsis patients after probiotic administration (time frame: Day 1 (T0) to Day 4 (T1) of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.