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

Phase 4

Not yet recruiting

• Conditions: Pneumonia; Probiotics; Diarrhea
• Interventions: Drug: Lacidofil; Drug: Placebo

• Registration Number: NCT06990568
• Lead Sponsor: National Health Insurance Service Ilsan Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-16
• Study First Submitted QC: 2025-05-23
• Last Update Submitted: 2025-05-23
• Study First Posted: 2025-05-25
• Last Update Posted: 2025-05-25
• Study Start: 2025-06-01
• Primary Completion: 2026-05-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lacidofil	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.
Placebo	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.

Primary Outcome Measures

Name	Time	Method
Occurrence of antibiotic-associated diarrhea	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 \[Liquid-like, no solid form, completely liquid\]

Secondary Outcome Measures

Name	Time	Method
Total length of hospitalization	Within 14 days after the cessation of Lacidofil or placebo administration	the duration from admission to discharge
Occurrence of Clostridium difficile infection	Within 14 days after the cessation of Lacidofil or placebo administration	Positive result in Clostridium difficile test: toxin, X-pert, or culture
Duration of antibiotic use	Within 14 days after the cessation of Lacidofil or placebo administration	period of antibiotic use during hospitalization + duration of oral antibiotic use after discharge