Effect of Probiotics on Atrial Fibrillation Outcome in Patients Undergoing Cardioversion
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Atrial Fibrillation Recurrence
研究概览
简要总结
The aim of this clinical study is to evaluate the efficacy and tolerability of probiotics on atrial fibrillation recurrence.
详细描述
Assessment of AF recurrence: Early AF recurrence is defined as relapse into AF within 1 week following successful cardioversion and AF recurrence through the study's 12-week follow-up.
Patients and Methods Design: Prospective, randomized, open label, controlled clinical trial
Patients: A total of 56 AF patients undergoing cardioversion will be randomly enrolled into one of 2 arms:
- Group 1 (Control group) (n=28): AF patients undergoing cardioversion who will receive the standard of care
- Group 2 (Probiotic group) (n = 28): AF patients undergoing cardioversion who will receive the standard of care in addition to probiotics DAILY orally administered (Probiotics 25 billion) after cardioversion for 12 weeks.
Groups (1 & 2) will be subjected to cardioversion on admission according to standard protocols and criteria.
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
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male aged 40 years or above with BMI less than 40
- •Persistent AF patients directly after cardioversion
排除标准
- •History of probiotic supplementation in the previous 6 weeks
- •Autoimmune diseases
- •Ongoing treatment with immunosuppressive therapies
- •Active Infection
- •Pregnant or breast-feeding patients
- •Active participation in another clinical study
- •History of or known allergy or intolerability to the study medications
研究组 & 干预措施
Experimental: Control group
28 AF patients undergoing cardioversion who will receive standard of care
干预措施: Anticoagulant Therapy (Drug)
Experimental: Probiotic group
28 AF patients undergoing cardioversion who will receive the standard of care in addition to Probiotics 25 billion daily orally, after cardioversion for 12 weeks
干预措施: Anticoagulant Therapy (Drug)
Experimental: Probiotic group
28 AF patients undergoing cardioversion who will receive the standard of care in addition to Probiotics 25 billion daily orally, after cardioversion for 12 weeks
干预措施: Probiotics capsules (Drug)
结局指标
主要结局
Atrial Fibrillation Recurrence
时间窗: 7 days
次要结局
- Atrial Fibrillation Recurrence(12 weeks)
研究者
Sarah Mostafa Mostafa Abdelfatah Raesah
Teaching Assistant and Researcher in Clinical Pharmacy Department, Faculty of Pharmacy, Ain Shams University.
Ain Shams University