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

November 5, 2010
May 14, 2013
March 2011
July 2011   (final data collection date for primary outcome measure)
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.
Gastric pH [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01237353 on ClinicalTrials.gov Archive Site
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
rabeprazole plasma concentrations [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of the Ability of Betaine Hydrochloride to Increase Stomach Acid in Healthy Volunteers
Pilot Study Evaluating Gastric Re-acidification Using Betaine Hydrochloride in Healthy Volunteers With Pharmacologically Induced Hypochlorhydria

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.

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.

Interventional
Not Provided
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pharmacodynamic
  • Dietary Supplement: betaine hydrochloride
    betaine hydrochloride 1500mg po x 1 on day 5
  • Drug: Rabeprazole
    rabeprazole po daily x 5 days
Experimental: betaine hydrochloride and rabeprazole
Interventions:
  • Dietary Supplement: betaine hydrochloride
  • Drug: Rabeprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
July 2011
July 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 59 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01237353
GastricpH-6264
No
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Leslie Benet, PhD University of California, San Francisco
University of California, San Francisco
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP