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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pneumonia; Diarrhea; Probiotics
• Intervention / Treatment: Drug: Lacidofil; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Eunki Chung, MD; Phone Number: +82-31-900-3235; Email: ekchung@nhimc.or.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 1 capsule twice daily.
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; 1 capsule twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]	Within 14 days after the cessation of Lacidofil or placebo administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of Clostridium difficile infection	Positive result in Clostridium difficile test: toxin, X-pert, or culture	Within 14 days after the cessation of Lacidofil or placebo administration
Total length of hospitalization	the duration from admission to discharge	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	Within 14 days after the cessation of Lacidofil or placebo administration

Collaborators and Investigators

• Sponsor: National Health Insurance Service Ilsan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 16, 2025
• First Submitted That Met QC Criteria: May 23, 2025
• First Posted (Actual): May 25, 2025

Study Record Updates

• Last Update Posted (Actual): May 25, 2025
• Last Update Submitted That Met QC Criteria: May 23, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Diarrhea
• Other Study ID Numbers: 2025-01-010; NHIMC-2024-CR-070 (Other Grant/Funding Number: National Health Insurance Service Ilsan Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes