PneumoniaPhase 4PROBIONCT06990568
Impact of Probiotics on Antibiotic-associated Diarrhea in Community-acquired Pneumonia
A Phase 4 study testing Lacidofil in people with Pneumonia and Probiotics, run by National Health Insurance Service Ilsan Hospital.
Trial summary
The study goal is to determine whether oral administration of a probiotic mixture can reduce the incidence of antibiotic-associated diarrhea in patients with community-acquired pneumonia. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Pneumonia, Probiotics, Diarrhea
- What is being tested?
- Lacidofil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 19 years or older admitted with a diagnosis of community-acquired pneumonia
- Patients eligible for oral medication administration (able to take oral or enteral feeding)
Who cannot join
- Sepsis patients
- Patients admitted to the intensive care unit (ICU) following endotracheal intubation
- Elderly patients aged 80 years or older
- Pregnant women
- Patients who have diarrhea at the time of admission
- Patients with a history of using probiotics within 3 months prior to admission
- Patients with a history of using laxatives within 1 week prior to admission
- Patients suspected of being in shock (mean arterial pressure < 65 mmHg) at the time of admission
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Probiotic Administration on the Incidence of Antibiotic-associated Diarrhea in Patients With Community-acquired Pneumonia
The study goal is to determine whether oral administration of a probiotic mixture can reduce the incidence of antibiotic-associated diarrhea in patients with community-acquired pneumonia.
- Conditions
- Pneumonia, Probiotics, Diarrhea
- Being tested
- Lacidofil, Placebo
- Medical subject headings
- Pneumonia, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LacidofilDrug
1 capsule twice daily.
PlaceboDrug
1 capsule twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Lacidofil | Experimental | Take 1 capsule of Lacidofil in the morning and evening after meals, for a total of 2 times a day. The total duration of the dosage is the antibiotic treatment period plus 5 days. Receives: Drug: Lacidofil |
| Placebo | Placebo comparator | Take 1 capsule of placebo in the morning and evening after meals, for a total of 2 times a day. The total duration of the dosage is the antibiotic treatment period plus 5 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of antibiotic-associated diarrhea
Antibiotic-Associated Diarrhea (Definition: Occurrence of diarrhea more than 3 times a day, occurring at least 24 hours after the first administration of antibiotics)
- Diarrhea is defined using the Bristol Stool Form Scale (BSF) as BSF 6 or 7. BSF 6: Mushy stool [Soft pieces with ragged edges, mushy stool] BSF 7: Watery stool [Liquid-like, no solid form, completely liquid]
Measured: Within 14 days after the cessation of Lacidofil or placebo administration
Secondary outcomes (3)
Occurrence of Clostridium difficile infection
Positive result in Clostridium difficile test: toxin, X-pert, or culture
Measured: Within 14 days after the cessation of Lacidofil or placebo administration
Total length of hospitalization
the duration from admission to discharge
Measured: Within 14 days after the cessation of Lacidofil or placebo administration
Duration of antibiotic use
period of antibiotic use during hospitalization + duration of oral antibiotic use after discharge
Measured: Within 14 days after the cessation of Lacidofil or placebo administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Insurance Service Ilsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eunki Chung, National Health Insurance Service Ilsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990568
- Sponsor's protocol ID
- 2025-01-010
- Other IDs
- NHIMC-2024-CR-070
- Acronym
- PROBIO
- Status last verified
- May 2025
- First submitted
- 16 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- 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 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotic Administration on the Incidence of Antibiotic-associated Diarrhea in Patients With Community-acquired Pneumonia
- ClinicalTrials.gov ID
- NCT06990568
- Acronym / sponsor ID
- PROBIO / 2025-01-010
- Conditions
- Pneumonia, Probiotics, Diarrhea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Health Insurance Service Ilsan HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 May 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.
The study goal is to determine whether oral administration of a probiotic mixture can reduce the incidence of antibiotic-associated diarrhea in patients with community-acquired pneumonia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lacidofil | Experimental | Drug: LacidofilTake 1 capsule of Lacidofil in the morning and evening after meals, for a total of 2 times a day. The total duration of the dosage is the antibiotic treatment period plus 5 days. |
| Placebo | Placebo comparator | Drug: PlaceboTake 1 capsule of placebo in the morning and evening after meals, for a total of 2 times a day. The total duration of the dosage is the antibiotic treatment period plus 5 days. |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients aged 19 years or older admitted with a diagnosis of community-acquired pneumonia
- Patients eligible for oral medication administration (able to take oral or enteral feeding)
Key exclusion criteria (8 listed)
- Sepsis patients
- Patients admitted to the intensive care unit (ICU) following endotracheal intubation
- Elderly patients aged 80 years or older
- Pregnant women
- Patients who have diarrhea at the time of admission
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 |
|---|---|---|
| Lacidofil1 capsule twice daily. | Drug | Lacidofil |
| Placebo1 capsule twice daily. | Drug | Placebo |
Primary outcome
Occurrence of antibiotic-associated diarrhea
Time frame: Within 14 days after the cessation of Lacidofil or placebo administration
Antibiotic-Associated Diarrhea (Definition: Occurrence of diarrhea more than 3 times a day, occurring at least 24 hours after the first administration of antibiotics) * Diarrhea is defined using the Bristol Stool Form Scale (BSF) as BSF 6 or 7. BSF 6: Mushy stool [Soft pieces with ragged edges, mushy stool] BSF 7: Watery stool [Liquid-like, no solid form, completely liquid]
3 secondary outcomes
Occurrence of Clostridium difficile infection
Time frame: Within 14 days after the cessation of Lacidofil or placebo administration
Total length of hospitalization
Time frame: Within 14 days after the cessation of Lacidofil or placebo administration
Duration of antibiotic use
Time frame: Within 14 days after the cessation of Lacidofil or placebo administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No
Related trials for Pneumonia
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lacidofil in people with Pneumonia and Probiotics, run by National Health Insurance Service Ilsan Hospital.
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 2 inclusion and 8 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: opening soon, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eunki Chung, MD (+82-31-900-3235, ekchung@nhimc.or.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of antibiotic-associated diarrhea (time frame: Within 14 days after the cessation of Lacidofil or placebo administration). 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 25 May 2025.