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

NCT06990568 | Not Yet Recruiting Phase 4

• 2 other identifiers: 2025-01-010NHIMC-2024-CR-070
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pneumonia; Probiotics; Diarrhea

Outcome Measures

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

  Within 14 days after the cessation of Lacidofil or placebo administration

Secondary Outcomes (3)

• Occurrence of Clostridium difficile infection

  Within 14 days after the cessation of Lacidofil or placebo administration

• Total length of hospitalization

  Within 14 days after the cessation of Lacidofil or placebo administration

• Duration of antibiotic use

  Within 14 days after the cessation of Lacidofil or placebo administration

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Lacidofil DRUG

1 capsule twice daily.

Lacidofil

Placebo DRUG

1 capsule twice daily.

Placebo

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Health Insurance Service Ilsan Hospital: lead

MeSH Terms

Conditions

Pneumonia; Diarrhea

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Eunki Chung, MD

CONTACT

+82-31-900-3235; ekchung@nhimc.or.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 25, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share