A Pilot Study of Probiotic Saccharomyces Boulardii Use in Chronic Heart Failure Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Analysis of biochemical profile (high-sensitivity C reactive protein, total leukocyte count and uric acid seric levels)
研究概览
简要总结
The purpose of this study is to evaluate the feasibility, safety and effects in inflammatory response of the therapy with a probiotic agent, the yeast Saccharomyces boulardii (SB), in chronic heart failure patients.
详细描述
A cardiointestinal syndrome has been described in heart failure patients, with morphologic and functional intestinal disorders, increased enteropathogenic bacteria concentration, bacterial translocation and inflammatory activation, thus contributing for clinical worsening and progression of the disease.
In clinical practice, probiotics has been used in several different conditions, as inflammatory bowel diseases, acute and antibiotic-associated diarrhea, food allergies, and cancer, showing benefits in inflammation and reducing bacterial translocation. However, the use of probiotics in heart failure has never been described.
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
- Triple (Participant, Care Provider, 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
- •Class I or II (NYHA)heart failure patients
排除标准
- •Corticosteroid use within 30 days
- •NSAID use within 30 days
- •Antibiotic use within 30 days
- •Acute infections
- •Inflammatory diseases
- •Autoimmune diseases
- •Intestinal diseases
- •Chronic renal failure
研究组 & 干预措施
Saccharomyces boulardii
干预措施: Saccharomyces boulardii (Drug)
Placebo
干预措施: Saccharomyces boulardii (Drug)
结局指标
主要结局
Analysis of biochemical profile (high-sensitivity C reactive protein, total leukocyte count and uric acid seric levels)
时间窗: 3 months
Analysis at baseline and after intervention
次要结局
- Analysis of cardiac remodelling(3 months)
- Analysis of creatinine seric levels(3 months)
研究者
Annelise Cisari Costanza
Principal investigator
Universidade Federal Fluminense