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

NCT01237353 | Completed Results

• 1 other identifier: GastricpH-6264
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pharmacodynamic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Duration of Gastric pH Status

  2 hours after dose of betaine HCl

Study Arms (1)

betaine hydrochloride and rabeprazole

EXPERIMENTAL

Dietary Supplement: betaine hydrochloride; Drug: Rabeprazole

Interventions

betaine hydrochloride DIETARY_SUPPLEMENT

betaine hydrochloride 1500mg po x 1 on day 5

betaine hydrochloride and rabeprazole

Rabeprazole DRUG

rabeprazole po daily x 5 days

betaine hydrochloride and rabeprazole

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Interventions

Betaine; Rabeprazole

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Leslie Benet
• Organization: University of California San Francisco

leslie.benet@ucsf.edu

415-476-3853

Study Officials

• Leslie Benet, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2010
• First Posted: November 9, 2010
• Study Start: March 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 2, 2013
• Results First Posted: July 2, 2013

Record last verified: 2013-05

Locations

US (1)