Pharmacodynamic
Conditions
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.
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.
Interventions
DIETARY_SUPPLEMENTbetaine hydrochloride
betaine hydrochloride 1500mg po x 1 on day 5
DRUGRabeprazole
rabeprazole po daily x 5 days
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gastric pH After Administration of Betaine Hydrochloride (HCl) | 30 minutes | 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
| Measure | Time frame | Description |
|---|---|---|
| Duration of Gastric pH Status | 2 hours after dose of betaine HCl | 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 |
Countries
United States
Participant flow
Recruitment details
Healthy volunteers were recruited to one clinical site in the U.S.
Pre-assignment details
Hypochlorhydria was induced through the administration of 20mg oral rabeprazole twice daily with food for four days prior to study day
Participants by arm
| Arm | Count |
|---|---|
| Betaine Hydrochloride and Rabeprazole betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5
Rabeprazole : rabeprazole po daily x 5 days | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Betaine Hydrochloride and Rabeprazole |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age Continuous | 39.83 years |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
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.
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Betaine Hydrochloride and Rabeprazole | Change in Gastric pH After Administration of Betaine Hydrochloride (HCl) | 4.54 units on a scale | Standard Deviation 0.46 |
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
Time frame: 2 hours after dose of betaine HCl
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Betaine Hydrochloride and Rabeprazole | Duration of Gastric pH Status | Mean time to pH <3.0 | 6.3 minutes | Standard Deviation 4.3 |
| Betaine Hydrochloride and Rabeprazole | Duration of Gastric pH Status | Mean minutes of pH < 3.0 | 72.5 minutes | Standard Deviation 32.9 |
| Betaine Hydrochloride and Rabeprazole | Duration of Gastric pH Status | Mean minutes of pH < 4.0 | 76.8 minutes | Standard Deviation 30.4 |