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

NCT ID: NCT00825630

Last Updated: 2022-12-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Helicobacter Pylori Infection

Keywords

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HP UBT PPI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Lansoprazole (Lanton)

Patients with H.pylori infection will take one tablet a day of 20 mg Lansoprazole for 14 days orally in the morning

Group Type ACTIVE_COMPARATOR

Lansoprazole (Lanton)

Intervention Type DRUG

Oral administration of Lanzoprazole for 14 days in 25 patients with H.pylori infection

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

Group Type ACTIVE_COMPARATOR

Omeprezole (Losec)

Intervention Type DRUG

Oral administration of Omeprazole for 14 days in 25 patients with H.pylori infection

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

Group Type ACTIVE_COMPARATOR

Pantoprazole(Controloc)

Intervention Type DRUG

Oral administration of Pantoprazole for 14 days in 25 patients with H.pylori infection

Esomeprazole(Nexium)

Patients with H.pylori infection will take one tablet a day of 20 mg Esomeprazole for 14 days orally on the morning

Group Type ACTIVE_COMPARATOR

Esomeprazole (Nexium)

Intervention Type DRUG

Oral administration of Esomeprazole for 14 days in 25 patients with H.pylori infection

Interventions

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Lansoprazole (Lanton)

Oral administration of Lanzoprazole for 14 days in 25 patients with H.pylori infection

Intervention Type DRUG

Omeprezole (Losec)

Oral administration of Omeprazole for 14 days in 25 patients with H.pylori infection

Intervention Type DRUG

Pantoprazole(Controloc)

Oral administration of Pantoprazole for 14 days in 25 patients with H.pylori infection

Intervention Type DRUG

Esomeprazole (Nexium)

Oral administration of Esomeprazole for 14 days in 25 patients with H.pylori infection

Intervention Type DRUG

Other Intervention Names

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Lanton Losec Controloc Nexium

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role collaborator

Meridian Bioscience, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Haim Shirin, MD

Role: PRINCIPAL_INVESTIGATOR

Sharon Hospital

Locations

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Rabin Medical Center

Petah Tikva, , Israel

Site Status

Countries

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Israel

References

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Shirin H, Frenkel D, Shevah O, Levine A, Bruck R, Moss SF, Niv Y, Avni Y. Effect of proton pump inhibitors on the continuous real time (13)C-urea breath test. Am J Gastroenterol. 2003 Jan;98(1):46-50. doi: 10.1111/j.1572-0241.2003.07187.x.

Reference Type RESULT
PMID: 12526935 (View on PubMed)

Other Identifiers

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HP-BID 608

Identifier Type: -

Identifier Source: org_study_id