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

National Health Insurance Service Ilsan Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: Diarrhea; Pneumonia; Probiotics

Treatments: Drug: Lacidofil; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06990568

NHIMC-2024-CR-070 (Other Grant/Funding Number)

2025-01-010

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 19 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Lacidofil

Experimental group

Description:

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.

Treatment:

Drug: Lacidofil

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo