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

NCT00825630 | Completed Phase 4 Results DMC

• 1 other identifier: HP-BID 608
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection

Keywords

HP; UBT; PPI

Outcome Measures

Primary Outcomes (1)

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

  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.

  17 days

Study Arms (4)

Lansoprazole (Lanton)

ACTIVE COMPARATOR

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)

Omeprazole (Losec)

ACTIVE COMPARATOR

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)

Pantoprazole (Controloc)

ACTIVE COMPARATOR

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)

Esomeprazole(Nexium)

ACTIVE COMPARATOR

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)

Interventions

Lansoprazole (Lanton) DRUG

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

Also known as: Lanton

Lansoprazole (Lanton)

Omeprezole (Losec) DRUG

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

Also known as: Losec

Omeprazole (Losec)

Pantoprazole(Controloc) DRUG

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

Also known as: Controloc

Pantoprazole (Controloc)

Esomeprazole (Nexium) DRUG

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

Also known as: Nexium

Esomeprazole(Nexium)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with H.pylori infection.

You may not qualify if:

• Pregnancy,
• Nursing,
• Antibiotic, bismuth or PPI treatment 2 weeks prior to trial,
• Known sensitivity to Urea or citrica.

Sponsors & Collaborators

• Meridian Bioscience, Inc.: lead
• Rabin Medical Center: collaborator

Study Sites (1)

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Related Publications (1)

• 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.

  PMID: 12526935 RESULT

MeSH Terms

Interventions

Lansoprazole; Omeprazole; Esomeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

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

Results Point of Contact

• Title: Dr. Haim Shirin
• Organization: Sharon Hospital

haims3@clalit.org.il

0097239372231

Study Officials

• Haim Shirin, MD

  Sharon Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2009
• First Posted: January 21, 2009
• Study Start: November 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: December 20, 2022
• Results First Posted: October 7, 2011

Record last verified: 2022-12

Locations

IL (1)