Pilot Study Evaluating Gastric Re-acidification Using Betaine Hydrochloride in Healthy Volunteers With Pharmacologically Induced Hypochlorhydria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change in Gastric pH After Administration of Betaine Hydrochloride (HCl)
研究概览
简要总结
In this study the investigators will test a nutritional supplement called betaine hydrochloride to see if it can temporarily increase the stomach acid in healthy volunteers who have decreased stomach acid because they take a medicine called rabeprazole.
详细描述
Investigators will evaluate the extent and time course of gastric re-acidification after oral betaine HCl in healthy volunteers with pharmacologically-induced hypochlorhydria. After betaine HCl dose, gastric pH will be continuously monitored for 2 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult with no active medical problems or significant chronic diseases as determined by the study doctor based on history, physical exam;
- •BMI between 18.5 - 35 kg/m2;
- •Taking no medications 2 weeks before and during the study enrollment, including drugs of abuse, prescription or OTC medications (except acetaminophen);
- •Subjects must be able to maintain adequate birth control during the study independent of hormonal contraceptive use;
- •Be able to provide written informed consent and comply with requirements of the study;
- •Avoid eating grapefruit and drinking grapefruit juice from 7 days before the first study day until completion of the entire study;
- •Abstinence from alcoholic beverages, caffeinated beverages and orange juice from 6pm the night before a study day until completion of that study day;
- •Fast from food and beverages at least 8 hours prior to the study day;
- •Be able to read, speak and understand English
排除标准
- •Subjects with a history of gastrointestinal disease including gastroesophageal reflux disease, gastritis, peptic ulcer disease or dyspepsia.
- •Subjects with a fasting gastric pH of > 4 (i.e. hypochlorhydria)
- •Subjects with history of dysphagia, achalasia, or difficulty swallowing capsules, tablets or pills.
- •Subjects on prescription or chronic over-the counter medications (including hormonal contraceptives);
- •Subjects with known allergy to study interventions;
- •Subjects who smoke tobacco;
- •Subjects with ongoing alcohol or illegal drug use;
- •Subjects who are pregnant, lactating or attempting to conceive;
- •Subjects unable to maintain adequate birth control during the study;
- •Subjects unable to follow protocol instructions or protocol criteria.
研究组 & 干预措施
betaine hydrochloride and rabeprazole
干预措施: betaine hydrochloride (Dietary Supplement)
betaine hydrochloride and rabeprazole
干预措施: Rabeprazole (Drug)
结局指标
主要结局
Change in Gastric pH After Administration of Betaine Hydrochloride (HCl)
时间窗: 30 minutes
Gastric pH levels monitored with a Heidelberg pH capsule (HC) which sends real-time signals to a computer system that visually plots intestinal pH on a minute-by-minute basis. When subject's pH remained above 4.0 for at least 15 minutes, a 1500 mg dose of betaine HCl was given orally with 90 mL of water, and gastric pH was continuously monitored for 2 hours.
次要结局
- Duration of Gastric pH Status(2 hours after dose of betaine HCl)