Health TrialsbyHealthPanel

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

ConditionsPneumoniaProbioticsDiarrhea
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19-79
SponsorNational Health Insurance Service Ilsan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Sepsis patients

Patients admitted to the intensive care unit (ICU) following endotracheal intubation

Elderly patients aged 80 years or older

Pregnant women

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lacidofil

    Drug

    1 capsule twice daily.

  • Placebo

    Drug

    1 capsule twice daily.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: LacidofilExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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

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

Secondary outcomes

1

Occurrence of Clostridium difficile infection

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

Time frame
Within 14 days after the cessation of Lacidofil or placebo administration
2

Total length of hospitalization

the duration from admission to discharge

Time frame
Within 14 days after the cessation of Lacidofil or placebo administration
3

Duration of antibiotic use

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

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Health Insurance Service Ilsan Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: