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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study Evaluating Gastric Re-acidification Using Betaine Hydrochloride in Healthy Volunteers With Pharmacologically Induced Hypochlorhydria

Conditions
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Pharmacodynamic

Intervention / Treatment
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* Dietary Supplement: betaine hydrochloride
* Drug: Rabeprazole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: betaine hydrochloride and rabeprazole<br> | Dietary Supplement: betaine hydrochloride<br>* betaine hydrochloride 1500mg po x 1 on day 5<br>Drug: Rabeprazole<br>* rabeprazole po daily x 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Gastric pH After Administration of Betaine Hydrochloride (HCl) | 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. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Gastric pH Status | 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 | 2 hours after dose of betaine HCl |