The Effectiveness of Probiotics for the Therapy of Acute Pharyngotonsillitis in Adult Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- period of disease
研究概览
简要总结
The addition of probiotics to the routine therapy of Acute Pharyngotonsillitis in adult patients may shorten the duration, and reduce the severity of the disease.
详细描述
Hypothesis The addition of probiotics to the routine therapy of AP in adult patients may shorten the duration, and reduce the severity of the disease.
Study design A prospective, randomized, placebo-controlled, double-blinded study comparing treatment with probiotics to placebo in patients with AP.
The study will be conducted in accordance with the ethical standards of the Helsinki Declaration and will be approved by the Human Experimentation Ethics Committee of the Ziv Medical Center. Signed informed consent will be required from all patients before inclusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years
- •Acute pharyngotonsillitis for which hospitalization for intravenous antibiotic treatment and/or fluids is needed
排除标准
- •Current therapy with systemic prednisone or equivalent at 20 mg/d for more than 10 days prior to inclusion
研究组 & 干预措施
Placebo
30 hospitalized patients will be given placebo with a regular penicillin treatment
干预措施: Placebo (Drug)
Probiotic
Probiotics will be given to 30 hospitalized patients with regular penicillin treatment
干预措施: Probiotics (Drug)
结局指标
主要结局
period of disease
时间窗: 10 days
Patients will be followed daily while hospitalized. After discharge patients will fill a daily dairy for 10 days and record symptoms, signs, drinking, eating, and return to normal life. All dairies will be collected on day 10 of the study.
次要结局
- analysis(10 days)