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

• Sponsor: Exalenz Bioscience LTD. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00825630
• Collaborator: Rabin Medical Center (Other)
• Enrollment: 123
• Location: 1
• Arms: 4
• Duration (Months): 12
• Patients Per Site Per Month: 10.3

Study Details

Study Description

Brief Summary

Approximately 200 patients with suspected H.pylori will be tested with a 13C-Urea Breath Test (UBT) to ascertain H.pylori positive. 100 H.Pylori positive patients will tested before and after prescribed with one of the four selected Proton Pump Inhibitors (PPIs); 25 patients in each arm. This will provide information on the influence of PPIs on the UBT (Urea Breath Test). The aim of the trial is to observe the effect of different PPIs on the breath test and choose the optimal protocol of when to stop PPI. The hypothesis is that there will be a minimal effect on the UBT while using selected PPIs.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Drug: Lansoprazole (Lanton); Drug: Omeprezole (Losec); Drug: Pantoprazole(Controloc); Drug: Esomeprazole (Nexium)	Phase 4

Detailed Description

Adult subjects with suspected H pylori infection will be recruited and will undergo a 13C -Urea breath test (including citrica) with the BreathID test device. Those were found positive will undergo selected PPI treatment for 14 days and after 24 or 72 hours from the completion of the two weeks, will undergo a second breath test. Those found to be negative (false negative), will undergo additional breath tests.

• Those subjects that underwent any antibiotic, bismuth or PPI therapy 4 weeks prior to the trial, are to be excluded.

• Furthermore, pregnant or nursing women and subjects with an allergy or sensitivity to one of the tests substrates, will be excluded from the study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 123 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: The Effect of High Dose Citric on PPI (Proton Pump Inhibitors)Induced False Negative H. Pylori UBT Rates
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Nov 1, 2009
• Actual Study Completion Date: Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lansoprazole (Lanton) Patients with H.pylori infection will take one tablet a day of 20 mg Lansoprazole for 14 days orally in the morning	Drug: Lansoprazole (Lanton); Oral administration of Lanzoprazole for 14 days in 25 patients with H.pylori infection; Other Names: Lanton
Active Comparator: Omeprazole (Losec) Patients with H.pylori infection will take one tablet of 30 mg a day of Omeprazole for 14 days orally in the morning	Drug: Omeprezole (Losec); Oral administration of Omeprazole for 14 days in 25 patients with H.pylori infection; Other Names: Losec
Active Comparator: Pantoprazole (Controloc) Patients with H.pylori infection will take one tablet a day of 40 mg of Pantoprazole for 14 days orally in the morning	Drug: Pantoprazole(Controloc); Oral administration of Pantoprazole for 14 days in 25 patients with H.pylori infection; Other Names: Controloc
Active Comparator: Esomeprazole(Nexium) Patients with H.pylori infection will take one tablet a day of 20 mg Esomeprazole for 14 days orally on the morning	Drug: Esomeprazole (Nexium); Oral administration of Esomeprazole for 14 days in 25 patients with H.pylori infection; Other Names: Nexium

Outcome Measures

Primary Outcome Measures

1. Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped. [17 days]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adults with H.pylori infection.

Exclusion Criteria:

• Pregnancy,

• Nursing,

• Antibiotic, bismuth or PPI treatment 2 weeks prior to trial,

• Known sensitivity to Urea or citrica.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rabin Medical Center	Petah Tikva		Israel	49100

Sponsors and Collaborators

• Exalenz Bioscience LTD.
• Rabin Medical Center

Investigators

• Principal Investigator: Haim Shirin, MD, Sharon Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Exalenz Bioscience LTD.
• ClinicalTrials.gov Identifier: NCT00825630
• Other Study ID Numbers: HP-BID 608
• First Posted: Jan 21, 2009
• Last Update Posted: Feb 16, 2012
• Last Verified: Feb 1, 2012

• Keywords provided by Exalenz Bioscience LTD.: HP; UBT; PPI
• Additional relevant MeSH terms: Esomeprazole; Pantoprazole; Lansoprazole; Dexlansoprazole

Study Results

Participant Flow

Recruitment Details	Two out-patient clinics in hospitals will enroll subjects
Pre-assignment Detail	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.

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

Baseline Characteristics

Arm/Group Title	Lansoprazole (Lanton)	Omeprazole( Losec)	Pantoprazole (Controloc)	Esomeprazole (Nexium)	Total
Arm/Group Description	Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days	Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days	Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days	Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days	Total of all reporting groups
Overall Participants	29	62	19	13	123
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	26 89.7%	55 88.7%	17 89.5%	9 69.2%	107 87%
>=65 years	3 10.3%	7 11.3%	2 10.5%	4 30.8%	16 13%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.86 (14.67)	52.48 (13.35)	51.84 (12.78)	55.38 (14.84)	52.46 (14.01)
Sex: Female, Male (Count of Participants)
Female	20 69%	40 64.5%	15 78.9%	7 53.8%	82 66.7%
Male	9 31%	22 35.5%	4 21.1%	6 46.2%	41 33.3%
Region of Enrollment (participants) [Number]
Israel	29 100%	62 100%	19 100%	13 100%	123 100%
H. Pyori Positive (particpants) [Number]
Number [particpants]	29	62	19	13	123

Outcome Measures

1. Primary Outcome

Title	Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped.
Description	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.
Time Frame	17 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Lansoprazole (Lanton)	Omeprazole( Losec)	Pantoprazole (Controloc)	Esomeprazole (Nexium)
Arm/Group Description	Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days	Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days	Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days	Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days
Measure Participants	29	62	19	13
False negatives (DOB<5) after 3 days of no PPI	1 3.4%	3 4.8%	1 5.3%	0 0%
False negatives (DOB<5) after 1 day of no PPI	2 6.9%	4 6.5%	2 10.5%	1 7.7%

Adverse Events

Arm/Group Title	Lansoprazole (Lanton)		Omeprazole( Losec)		Pantoprazole (Controloc)		Esomeprazole (Nexium)
Arm/Group Description	Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days		Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days		Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days		Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days
All Cause Mortality
	Lansoprazole (Lanton)		Omeprazole( Losec)		Pantoprazole (Controloc)		Esomeprazole (Nexium)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Lansoprazole (Lanton)		Omeprazole( Losec)		Pantoprazole (Controloc)		Esomeprazole (Nexium)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/62 (0%)		0/19 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	Lansoprazole (Lanton)		Omeprazole( Losec)		Pantoprazole (Controloc)		Esomeprazole (Nexium)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/62 (0%)		0/19 (0%)		0/13 (0%)

Limitations/Caveats

It was hard to get people to agree to return for multiple tests within a few days, so the enrollment was difficult

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.