Study of the Ability of Betaine Hydrochloride to Increase Stomach Acid in Healthy Volunteers

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
betaine hydrochloride and rabeprazole	betaine hydrochloride	-
betaine hydrochloride and rabeprazole	Rabeprazole	-

Primary Outcome Measures

Name	Time	Method
Change in Gastric pH After Administration of Betaine Hydrochloride (HCl)	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.

Secondary Outcome Measures

Name	Time	Method
Duration of Gastric pH Status	2 hours after dose of betaine HCl	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