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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| betaine hydrochloride and rabeprazole | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| betaine hydrochloride | Dietary Supplement | betaine hydrochloride 1500mg po x 1 on day 5 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie Benet, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States |
Hypochlorhydria was induced through the administration of 20mg oral rabeprazole twice daily with food for four days prior to study day
Healthy volunteers were recruited to one clinical site in the U.S.
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| ID | Title | Description |
|---|---|---|
| FG000 | Betaine Hydrochloride and Rabeprazole | betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5 Rabeprazole : rabeprazole po daily x 5 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Betaine Hydrochloride and Rabeprazole | betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5 Rabeprazole : rabeprazole po daily x 5 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 30 minutes |
|
|
2 hours after betaine HCl dose, or by report of subject
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Betaine Hydrochloride and Rabeprazole | betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5 Rabeprazole : rabeprazole po daily x 5 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Leslie Benet | University of California San Francisco | 415-476-3853 | leslie.benet@ucsf.edu |
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| ID | Term |
|---|---|
| D001622 | Betaine |
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Rabeprazole | Drug | rabeprazole po daily x 5 days |
|
| Participants |
|
| Age Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 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 | Posted | Mean | Standard Deviation | minutes | 2 hours after dose of betaine HCl |
|
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| 0 |
| 6 |
| 0 |
| 6 |
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| D009861 |
| Onium Compounds |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Title | Measurements |
|---|
|