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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01237353
First received: November 5, 2010
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Pharmacodynamic
Dietary Supplement: betaine hydrochloride
Drug: Rabeprazole

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study Evaluating Gastric Re-acidification Using Betaine Hydrochloride in Healthy Volunteers With Pharmacologically Induced Hypochlorhydria

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Change in Gastric pH After Administration of Betaine Hydrochloride (HCl) [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    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:
  • Duration of Gastric pH Status [ Time Frame: 2 hours after dose of betaine HCl ] [ Designated as safety issue: No ]
    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


Enrollment: 6
Study Start Date: March 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: betaine hydrochloride and rabeprazole Dietary Supplement: betaine hydrochloride
betaine hydrochloride 1500mg po x 1 on day 5
Drug: Rabeprazole
rabeprazole po daily x 5 days

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.

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01237353

Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Leslie Benet, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01237353     History of Changes
Other Study ID Numbers: GastricpH-6264
Study First Received: November 5, 2010
Results First Received: May 14, 2013
Last Updated: May 14, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Rabeprazole
Betaine
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents

ClinicalTrials.gov processed this record on September 18, 2014