Pneumonia, Probiotics, Diarrhea
Conditions
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.
Interventions
DRUGLacidofil
1 capsule twice daily.
DRUGPlacebo
1 capsule twice daily.
Sponsors
National Health Insurance Service Ilsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Total length of hospitalization | Within 14 days after the cessation of Lacidofil or placebo administration | the duration from admission to discharge |
| 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 |
Contacts
Primary ContactEunki Chung, MD
Outcome results
None listed