NCT00002088已完成2 期
Treatment of Patients With Human Immunodeficiency Virus (HIV)-Related Chronic Diarrhea With Saccharomyces Boulardii or Placebo: A Double Blind Trial
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Biocodex
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
To assess the efficacy of Saccharomyces boulardii (a nonpathogenic yeast) in producing a significant reduction in diarrheal symptoms in HIV-infected patients with chronic diarrhea.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- Double
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
- •Concurrent Medication:
- •Antiviral medication for HIV infection.
- •Patients must have:
- •Documented HIV infection.
- •Chronic diarrhea (for at least 1 month) that is either a manifestation or complication of documented HIV infection.
- •Had a stool culture (Salmonella, Shigella, Campylobacter, and Clostridium difficile) and stool analysis for ova and parasite (O/P X 3) within the past 2 months.
- •Failed antimicrobial treatment for diarrhea OR received no prior antimicrobials for stool pathogens because stool cultures were negative.
- •Patients who are on antiviral medications for HIV infection must have received such medication for at least 2 weeks and must remain on stable dose for weeks 1 and 2 of study.
- •Prior Medication:
- •Prior antiviral medication for HIV infection (if on such medication, must have received it for at least 2 weeks).
- •Standard antimicrobial therapy for a documented positive gastrointestinal pathogen.
排除标准
- •Concurrent Medication:
- •Gastrointestinal medications that cause diarrhea (e.g., magnesium-containing antacids, lactulose).
- •Maintenance antifungal medication for life-threatening fungal infections (other than fluconazole <= 100 mg/day).
研究者
研究点 (1)
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