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| ID | Type | Description | Link |
|---|---|---|---|
| NHIMC-2024-CR-070 | Other Grant/Funding Number | National Health Insurance Service Ilsan Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lacidofil | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacidofil | Drug | 1 capsule twice daily. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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] | Within 14 days after the cessation of Lacidofil or placebo administration |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Clostridium difficile infection | Positive result in Clostridium difficile test: toxin, X-pert, or culture | Within 14 days after the cessation of Lacidofil or placebo administration |
| Total length of hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eunki Chung, MD | Contact | +82-31-900-3235 | ekchung@nhimc.or.kr |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Drug |
1 capsule twice daily. |
|
the duration from admission to discharge
| Within 14 days after the cessation of Lacidofil or placebo administration |
| Duration of antibiotic use | period of antibiotic use during hospitalization + duration of oral antibiotic use after discharge | Within 14 days after the cessation of Lacidofil or placebo administration |
| D012817 |
| Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |