Comparison Study Between C13-CAC Breath Test and 24-hour Gastric pH Monitoring

Unblinded Comparison Study for Relationship and Reproducibility Between C13-CAC Breath Test and 24-hour Gastric pH Monitoring, in Patients With Acid-related Diseases and Healthy Volunteers

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02225067

Enrollment

Registered

2014-08-25

Start date

2014-08-31

Completion date

2014-12-31

Last updated

2015-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Acid-related Diseases, Healthy

Keywords

Patients, Volunteers

Brief summary

The purpose of this study is to compare C13-CAC Breath Test with 24-hour Gastric pH Monitoring in Patients with Gastric Acid-related Diseases and Healthy Volunteers

Interventions

DRUGCalcium (13C)Carbonate

Visit 1 and Visit 2, 24-hour gastric pH monitoring and C13-CAC breath test containing 200 mg of Calcium (13C)Carbonate

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* Patients with Gastric Acid-related diseases like peptic ulcer or gastroesophageal reflux disease in investigator's judgment * Healthy subjects who are determined no history of Helicobacter pylori infections

Exclusion criteria

* Patients with hypercalcemia * Patients with hypothyroidism * Patients with hyperparathyroidism * History of upper gastrointestinal surgery or resection * Any condition would limit the subject's ability to complete 24-hour gastric pH monitoring

Design outcomes

Primary

Measure	Time frame	Description
13CO2 concentration in expired air	5，10，15，20，25，30，40，50，60，80，100 and 120minutes after C13-CAC administration	13CO2 concentration in expired air, 13CO2 excretion rate in expired air as well as the pharmacokinetic parameters (Cmax, AUCt, AUC∞, tmax, λz, and t1/2) determined from the 13CO2 concentration in expired air and 13CO2 excretion rate in expired air
24-hour gastric pH	from completion of pre-study examination to before C13-CAC adminitration	Gastric pH immediately before taking the C13-CAC and mean gastric pH from a specified time point to the time before C13-CAC administration

Other

Measure	Time frame	Description
Gastric pH holding time ratio	from completion of pre-study examination to before C13-CAC adminitration	pH 3 holding time ratio and pH 4 holding time ratio in the 24-hour gastric pH monitoring

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026