The Effect of Spirulina Platensis on Rebound Dyspeptic Symptoms After Discontinuation of Proton Pump Inhibitors: a Phase 2 Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 主要终点
- Number of participants with dyspeptic symptoms
研究概览
简要总结
Background: Rebound acid hypersecretion after proton pump inhibitors (PPIs) discontinuation may be accompanied by dyspepsia.
Aim: To assess whether Spirulina platensis, by its anti-inflammatory properties, could minimize rebound symptoms after PPIs withdrawal.
详细描述
Forty-five regular users of PPIs entered in a 28-day run-in phase of pantoprazole 40 mg/day, followed by clinical and endoscopic evaluation. In the absence of large hiatal hernia, peptic ulcer, or moderate to severe reflux esophagitis, patients stopped PPIs and were randomly assigned to receive Spirulina (1.6 g/day) or placebo for 2 months, when evaluation was repeated. Primary outcomes were dyspepsia and typical reflux symptoms (either appearance or maintenance of symptoms > 50% from baseline). Intention-to-treat analysis was applied.
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)
盲法说明
Capsules containing Spirulina and placebo were identical
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic use of any PPIs, either original brand or generic
- •Absence of conditions that contraindicate the cessation of PPIs, such as active or recent peptic ulcer, active or recent upper digestive bleeding, regular use of salicylates or non-steroidal anti-inflammatory drugs, moderate to severe reflux esophagitis, and sliding hiatal hernia greater than 3 cm
- •Formal agreement to participate
排除标准
- •Uncompensated acute and chronic morbidities
- •Gastroesophageal surgery
- •Cognitive deficit
结局指标
主要结局
Number of participants with dyspeptic symptoms
时间窗: 60 days
Relapse of dyspeptic symptoms after PPIs cessation
Number of participants with typical GERD symptoms
时间窗: 60 days
Relapse of typical GERD symptoms
次要结局
- Rate of new endoscopic lesions(60 days)
- Number of participants with microscopic changes in the stomach(60 days)
- Number of participants with side effects(60 days)
研究者
Fernando Fornari
Professor
Universidade de Passo Fundo