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

Pharmacodynamic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01237353
• Other study ID #: GastricpH-6264
• Status: Completed
• Phase: N/A
• First received: November 5, 2010
• Last updated: May 14, 2013
• Start date: March 2011
• Est. completion date: July 2011

Study information

• Verified date: May 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 59 Years

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.

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pharmacodynamic

Intervention

Dietary Supplement:
• betaine hydrochloride
betaine hydrochloride 1500mg po x 1 on day 5

Drug:
• Rabeprazole
rabeprazole po daily x 5 days

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No