Trial Outcomes & Findings for 13-C Urea Breath Test Using BreathID System and PPIs (Proton Pump Inhibitors) (NCT NCT00825630)

NCT ID: NCT00825630

Last Updated: 2022-12-20

Results Overview

Negative value is defined as delta over baseline (DOB) less than 5. The subjects who were positive (DOB\>=5) for H.Pylori and after PPI for 10 days repeated a breath with a negative (DOB\<5) were considered false negatives. The breath test has been cleared by the FDA in a 510(k) and has \> 96% accuracy.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 123 participants
• Primary outcome timeframe: 17 days
• Results posted on: 2022-12-20

Participant Flow

Two out-patient clinics in hospitals will enroll subjects

Size of arms varied due availability of PPI (proton pump inhibitors) and desire to gather more data in most common PPIs.Ethics committees approved additional recruitment.

Participant milestones

Measure	Lansoprazole (Lanton) Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days	Omeprazole( Losec) Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days	Pantoprazole (Controloc) Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days	Esomeprazole (Nexium) Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days
Overall Study STARTED	29	62	19	13
Overall Study COMPLETED	29	62	19	13
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

13-C Urea Breath Test Using BreathID System and PPIs (Proton Pump Inhibitors)

Baseline characteristics by cohort

Measure	Lansoprazole (Lanton) n=29 Participants Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days	Omeprazole( Losec) n=62 Participants Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days	Pantoprazole (Controloc) n=19 Participants Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days	Esomeprazole (Nexium) n=13 Participants Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days	Total n=123 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants	55 Participants n=7 Participants	17 Participants n=5 Participants	9 Participants n=4 Participants	107 Participants n=21 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	7 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	16 Participants n=21 Participants
Age, Continuous	52.86 years STANDARD_DEVIATION 14.67 • n=5 Participants	52.48 years STANDARD_DEVIATION 13.35 • n=7 Participants	51.84 years STANDARD_DEVIATION 12.78 • n=5 Participants	55.38 years STANDARD_DEVIATION 14.84 • n=4 Participants	52.46 years STANDARD_DEVIATION 14.01 • n=21 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	40 Participants n=7 Participants	15 Participants n=5 Participants	7 Participants n=4 Participants	82 Participants n=21 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	22 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	41 Participants n=21 Participants
Region of Enrollment Israel	29 participants n=5 Participants	62 participants n=7 Participants	19 participants n=5 Participants	13 participants n=4 Participants	123 participants n=21 Participants
H. Pyori Positive	29 particpants n=5 Participants	62 particpants n=7 Participants	19 particpants n=5 Participants	13 particpants n=4 Participants	123 particpants n=21 Participants

PRIMARY outcome

Timeframe: 17 days

Population: Analysis was done on an ITT basis and approximately 25 subjects per group were anticipated in order to obtain a general evaluation of which PPI is will cause the least amount of false negatives.The actual amount of subjects in each group will depend upon the availability of the different PPIs through the course of the study.

Negative value is defined as delta over baseline (DOB) less than 5. The subjects who were positive (DOB>=5) for H.Pylori and after PPI for 10 days repeated a breath with a negative (DOB<5) were considered false negatives. The breath test has been cleared by the FDA in a 510(k) and has > 96% accuracy.

Outcome measures

Measure	Lansoprazole (Lanton) n=29 Participants Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days	Omeprazole( Losec) n=62 Participants Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days	Pantoprazole (Controloc) n=19 Participants Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days	Esomeprazole (Nexium) n=13 Participants Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days
Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped. False negatives (DOB<5) after 3 days of no PPI	1 participants	3 participants	1 participants	0 participants
Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped. False negatives (DOB<5) after 1 day of no PPI	2 participants	4 participants	2 participants	1 participants

Adverse Events

Lansoprazole (Lanton)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Omeprazole( Losec)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pantoprazole (Controloc)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Esomeprazole (Nexium)

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. Haim Shirin

Sharon Hospital

Phone: 0097239372231

Email: haims3@clalit.org.il

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place