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

NCT ID: NCT06990568

Last Updated: 2025-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pneumonia Probiotics Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lacidofil

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.

Group Type EXPERIMENTAL

Lacidofil

Intervention Type DRUG

1 capsule twice daily.

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 capsule twice daily.

Interventions

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Lacidofil

1 capsule twice daily.

Intervention Type DRUG

Placebo

1 capsule twice daily.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Health Insurance Service Ilsan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Eunki Chung

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Eunki Chung, MD

Role: CONTACT

+82-31-900-3235

Other Identifiers

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NHIMC-2024-CR-070

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2025-01-010

Identifier Type: -

Identifier Source: org_study_id

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