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NCT Number: NCT06990568

Impact of Probiotics on Antibiotic-associated Diarrhea in 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.

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Key information

Conditions

Pneumonia Diarrhea Infections Lung Diseases Pathological Conditions, Signs and Symptoms Probiotics Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Digestive

Age range

19 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lacidofil

Drug

1 capsule twice daily.

Placebo

Drug

1 capsule twice daily.

Primary outcomes

  1. Occurrence of antibiotic-associated diarrhea

    Time frame: 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 outcomes

  1. Occurrence of Clostridium difficile infection

    Time frame: Within 14 days after the cessation of Lacidofil or placebo administration

    Positive result in Clostridium difficile test: toxin, X-pert, or culture

  2. Total length of hospitalization

    Time frame: Within 14 days after the cessation of Lacidofil or placebo administration

    the duration from admission to discharge

  3. Duration of antibiotic use

    Time frame: Within 14 days after the cessation of Lacidofil or placebo administration

    period of antibiotic use during hospitalization + duration of oral antibiotic use after discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Eunki Chung, MD

CONTACT

[email protected]

+82-31-900-3235

Sponsors and collaborators

Lead sponsor

National Health Insurance Service Ilsan Hospital

Other

Registry information

Official study title

The Effect of Probiotic Administration on the Incidence of Antibiotic-associated Diarrhea in Patients With Community-acquired Pneumonia

Acronym: PROBIO

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 25, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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