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Not yet recruitingNCT06990568PROBIOUpdated May 25, 2025

Impact of Probiotics on Antibiotic-associated Diarrhea in Community-acquired Pneumonia

A Phase 4 interventional study of Lacidofil and Placebo in Pneumonia, Probiotics and Diarrhea, sponsored by National Health Insurance Service Ilsan Hospital. Not yet recruiting. Open to participants aged 19 Years to 79 Years. Per ClinicalTrials.gov, last updated 2025-05-25.

Sponsored by National Health Insurance Service Ilsan Hospital · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
19 Years to 79 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pneumonia
  • Probiotics
  • Diarrhea
03

In context

Pneumonia

1,564 studies on the registry are indexed under Pneumonia; 265 are open to participants now.

This study's planned enrollment of 100 is below the median of 129 across 975 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

National Health Insurance Service Ilsan Hospital is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Lacidofil

    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.

    Drug: Lacidofil

  • Placebo comparator
    Placebo

    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.

    Drug: Placebo

Interventions

  • DrugLacidofil

    1 capsule twice daily.

  • DrugPlacebo

    1 capsule twice daily.

06

What researchers measure

Primary outcomes

  1. 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 \[Liquid-like, no solid form, completely liquid\]

    Time frame: Within 14 days after the cessation of Lacidofil or placebo administration

Secondary outcomes

  1. Occurrence of Clostridium difficile infection

    Positive result in Clostridium difficile test: toxin, X-pert, or culture

    Time frame: Within 14 days after the cessation of Lacidofil or placebo administration

  2. Total length of hospitalization

    the duration from admission to discharge

    Time frame: Within 14 days after the cessation of Lacidofil or placebo administration

  3. Duration of antibiotic use

    period of antibiotic use during hospitalization + duration of oral antibiotic use after discharge

    Time frame: Within 14 days after the cessation of Lacidofil or placebo administration

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06990568
Lead sponsor
National Health Insurance Service Ilsan Hospital
Responsible party
Eunki Chung (MD, National Health Insurance Service Ilsan Hospital) — Principal investigator
First posted
May 25, 2025
Start date
Jun 1, 2025 (estimated)
Primary completion
May 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
May 25, 2025

Study contacts

Eunki Chung, MD
Contact
ekchung@nhimc.or.kr
+82-31-900-3235

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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