Is it Effective to Treat Patients With Blastocystis Hominis Infection? A Double-blind Placebo Controlled Randomized Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Improvement of gastro-intestinal symptoms
研究概览
简要总结
The objective of this study is to determine whether in the setting of primary health care it is effective to treat with metronidazole returning travellers with gastrointestinal symptoms and B. hominis in the stool or not.
详细描述
Prevalence of B. hominis is between 30-50% in developing countries. Many travellers visit developing countries and are therefore at risk to be infected by this parasite. It's frequent that travellers return from developing countries with gastro-intestinal symptoms and approximately 10% of them have B. hominis as the sole parasite identified in the stools. Some anti-infective drugs, including metronidazole, trimethoprim-sulfamethoxazole and nitazoxanide, have shown to have activity against B. hominis, but there is still controversy about the pathogenic potential of B. hominis and there is no consensus about the indications for treatment.
It is hypothesised that metronidazole is more effective than placebo in returning travellers with gastrointestinal symptoms and B. hominis as the sole intestinal parasite identified in the stool.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •≥ 18 years
- •Gastrointestinal symptoms for more than 10 days
- •B. hominis in any quantity in at least one stool specimen out of 3 examined
- •No other pathogenic micro-organism identified
排除标准
- •Fever > 37.5°
- •bloody diarrhoea
- •weight loss > 10% of usual body weight
- •significant decrease of general condition
- •oncological diseases
- •immune deficiencies
- •known chronic intestinal diseases
- •use of anti-protozoan drugs in the last 2 weeks
- •use of anti-coagulant treatment or antabuse
- •pregnant and lactating women
研究组 & 干预措施
Metronidazole
Metronidazole 3x500 mg per day for 10 days
干预措施: Metronidazole (Drug)
Placebo
Placebo 3x1 tablet per day for 10 days
干预措施: Placebo (Drug)
结局指标
主要结局
Improvement of gastro-intestinal symptoms
时间窗: 10-14 days after treatment with Metronidazol
The improvement of the following symptoms will be evaluated: * Presence of unusually soft or unformed stools in the last 3 days (yes or no) * Average number of stools per day in the last 3 days * Maximal abdominal pain in the last 3 days on a scale from 0-10 * Bloating in last 3 days on a scale from 0-10 * Flatulence in last 3 days on a scale from 0-10
次要结局
未报告次要终点
研究者
Serge de Valliere
MD, MSc, Consultant, Principal Investigator
University of Lausanne Hospitals