PharmacodynamicNCT01237353

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

A study testing betaine hydrochloride and Rabeprazole in people with Pharmacodynamic, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for: Pharmacodynamic
What is being tested?: betaine hydrochloride and Rabeprazole
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: Mar 2011to Jul 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 59 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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;

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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

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of California San Francisco
San Francisco, California, 94143

Other trials in United States

About this study

Official title: Pilot Study Evaluating Gastric Re-acidification Using Betaine Hydrochloride in Healthy Volunteers With Pharmacologically Induced Hypochlorhydria

Read the 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.

Conditions: Pharmacodynamic
Being tested: betaine hydrochloride, Rabeprazole

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

betaine hydrochlorideDietary supplement
betaine hydrochloride 1500mg po x 1 on day 5
RabeprazoleDrug
rabeprazole po daily x 5 days

Study groups in NCT01237353
Study group	Role	What they receive
betaine hydrochloride and rabeprazole	Experimental	Not described Receives: Dietary Supplement: betaine hydrochloride; Drug: Rabeprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 30 minutes

Secondary outcomes (1)

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
Measured: 2 hours after dose of betaine HCl

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2011Jul 2011

First posted9 Nov 2010 (estimated)
Study startMar 2011
Primary completionJul 2011
Study completionJul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PharmacodynamicStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01237353
Sponsor's protocol ID: GastricpH-6264
Status last verified: May 2013
First submitted: 5 Nov 2010
Last updated: 2 Jul 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pharmacodynamic trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study Evaluating Gastric Re-acidification Using Betaine Hydrochloride in Healthy Volunteers With Pharmacologically Induced Hypochlorhydria
ClinicalTrials.gov ID: NCT01237353
Acronym / sponsor ID: GastricpH-6264
Conditions: Pharmacodynamic
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Study start: Mar 2011
Primary completion: Jul 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 9 Nov 2010 (estimated)
Results: Posted 2 Jul 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
betaine hydrochloride and rabeprazole	Experimental	Dietary Supplement: betaine hydrochloride, Drug: Rabeprazole

Who may qualify

Ages: 18 to 59 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

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;

Key exclusion criteria (10 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
betaine hydrochloridebetaine hydrochloride 1500mg po x 1 on day 5	Dietary supplement	betaine hydrochloride and rabeprazole
Rabeprazolerabeprazole po daily x 5 days	Drug	betaine hydrochloride and rabeprazole

Primary outcome

Change in Gastric pH After Administration of Betaine Hydrochloride (HCl)
Time frame: 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.

1 secondary outcome

Duration of Gastric pH Status
Time frame: 2 hours after dose of betaine HCl

Results and safety

Results posted to the registry on 2 Jul 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Betaine Hydrochloride and Rabeprazole	6	6

Primary outcome: Change in Gastric pH After Administration of Betaine Hydrochloride (HCl)

Time frame: 30 minutes. Mean (Standard Deviation). Unit: units on a scale

Measure	Betaine Hydrochloride and Rabeprazole n = 6
Value	4.54 (0.46)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 2 hours after betaine HCl dose, or by report of subject. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Betaine Hydrochloride and Rabeprazole	0 of 6 (0%)	0 of 6 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
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RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
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Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Leslie Benet, PhD principal investigator

University of California, San Francisco

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing betaine hydrochloride and Rabeprazole in people with Pharmacodynamic, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Gastric pH After Administration of Betaine Hydrochloride (HCl) (time frame: 30 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01237353.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2013.