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

University of California San Francisco (UCSF)

Status

Completed

Conditions

Pharmacodynamic

Treatments

Drug: Rabeprazole

Dietary Supplement: betaine hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT01237353

GastricpH-6264

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

18 to 59 years old

Volunteers

Accepts Healthy Volunteers

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.