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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01237353
Recruitment Status : Completed
First Posted : November 9, 2010
Results First Posted : July 2, 2013
Last Update Posted : July 2, 2013
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Pharmacodynamic
Interventions: Dietary Supplement: betaine hydrochloride
Drug: Rabeprazole

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Healthy volunteers were recruited to one clinical site in the U.S.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Hypochlorhydria was induced through the administration of 20mg oral rabeprazole twice daily with food for four days prior to study day

Reporting Groups
Betaine Hydrochloride and Rabeprazole

betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5

Rabeprazole : rabeprazole po daily x 5 days

Participant Flow:   Overall Study
    Betaine Hydrochloride and Rabeprazole

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Betaine Hydrochloride and Rabeprazole

betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5

Rabeprazole : rabeprazole po daily x 5 days

Baseline Measures
   Betaine Hydrochloride and Rabeprazole 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   6 
>=65 years   0 
[Units: Years]
Mean (Full Range)
 (25 to 57) 
[Units: Participants]
Female   2 
Male   4 
Region of Enrollment 
[Units: Participants]
United States   6 

  Outcome Measures

1.  Primary:   Change in Gastric pH After Administration of Betaine Hydrochloride (HCl)   [ Time Frame: 30 minutes ]

2.  Secondary:   Duration of Gastric pH Status   [ Time Frame: 2 hours after dose of betaine HCl ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Dr. Leslie Benet
Organization: University of California San Francisco
phone: 415-476-3853
e-mail: leslie.benet@ucsf.edu

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01237353     History of Changes
Other Study ID Numbers: GastricpH-6264
First Submitted: November 5, 2010
First Posted: November 9, 2010
Results First Submitted: May 14, 2013
Results First Posted: July 2, 2013
Last Update Posted: July 2, 2013