The Effect of Probiotic Administration on the Incidence of Antibiotic-associated Diarrhea in Patients With Community-acquired Pneumonia
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Occurrence of antibiotic-associated diarrhea
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Lacidofil (Drug)
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Occurrence of antibiotic-associated diarrhea
时间窗: 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 \[Liquid-like, no solid form, completely liquid\]
次要结局
- Total length of hospitalization(Within 14 days after the cessation of Lacidofil or placebo administration)
- Duration of antibiotic use(Within 14 days after the cessation of Lacidofil or placebo administration)
- Occurrence of Clostridium difficile infection(Within 14 days after the cessation of Lacidofil or placebo administration)
研究者
Eunki Chung
MD
National Health Insurance Service Ilsan Hospital