Trial Outcomes & Findings for Study of the Ability of Betaine Hydrochloride to Increase Stomach Acid in Healthy Volunteers (NCT NCT01237353)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

30 minutes

Results posted on

2013-07-02

Participant Flow

Healthy volunteers were recruited to one clinical site in the U.S.

Hypochlorhydria was induced through the administration of 20mg oral rabeprazole twice daily with food for four days prior to study day

Participant milestones

Participant milestones
Measure	Betaine Hydrochloride and Rabeprazole betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5 Rabeprazole : rabeprazole po daily x 5 days
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Betaine Hydrochloride and Rabeprazole n=6 Participants betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5 Rabeprazole : rabeprazole po daily x 5 days
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	39.83 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Betaine Hydrochloride and Rabeprazole n=6 Participants betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5 Rabeprazole : rabeprazole po daily x 5 days
Change in Gastric pH After Administration of Betaine Hydrochloride (HCl)	4.54 units on a scale Standard Deviation 0.46

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Betaine Hydrochloride and Rabeprazole n=6 Participants betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5 Rabeprazole : rabeprazole po daily x 5 days
Duration of Gastric pH Status Mean minutes of pH < 4.0	76.8 minutes Standard Deviation 30.4
Duration of Gastric pH Status Mean time to pH <3.0	6.3 minutes Standard Deviation 4.3
Duration of Gastric pH Status Mean minutes of pH < 3.0	72.5 minutes Standard Deviation 32.9

Adverse Events

Betaine Hydrochloride and Rabeprazole

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Leslie Benet

University of California San Francisco

Phone: 415-476-3853

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place