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©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Aug 28, 2017; 23(32): 5954-5961
Published online Aug 28, 2017. doi: 10.3748/wjg.v23.i32.5954
Published online Aug 28, 2017. doi: 10.3748/wjg.v23.i32.5954
Modified Helicobacter test using a new test meal and a 13C-urea breath test in Helicobacter pylori positive and negative dyspepsia patients on proton pump inhibitors
Bojan Tepeš, AM DC Rogaška, Prvomajska 29 A, 3250 Rogaška Slatina, Slovenia
Peter Malfertheiner, Universitätsklinikum Magdeburg A. ö. R Klinik für Gastroenterologie, Hepatologie und Infektiologie, 39120 Magdeburg, Germany
Joachim Labenz, Department of Internal Medicine and Gastroenterology, Diakonie Klinikum, Jung-Stilling Hospital, 57074 Siegen, Germany
Sitke Aygen, Institut für Biomedizinische Analytik und NMR-Imaging GmbH (INFAI), Gottfried-Hagen-Str. 6062, 51105 Köln, Germany
Author contributions: Aygen S prepared the study protocol, statistics, final report of the study and contributed to the manuscript; Tepeš B contributed to the design of the study, performed the research and prepared the manuscript; Malfertheiner P and Labenz J performed the research; all authors approved the final version of the manuscript.
Institutional review board statement: The study was reviewed and approved by the institutional review boards of AM DC Rogaška, Slovenia, Universitätsklinikum Magdeburg Magdeburg, Germany, Diakonie Klinikum, Siegen, Germany.
Clinical trial registration statement: The study was registered under EudraCT Number: 2008-008010-39.
Informed consent statement: All study participants, or their legal guardian, provided written consent prior to study enrollment.
Conflict-of-interest statement: The authors of this manuscript having no conflicts of interest to disclose.
Data sharing statement: There is no additional data available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Bojan Tepeš, MD, PhD, FEBGH, Professor, AM DC Rogaška, Prvomajska 29A, 3250 Rogaška Slatina, Slovenia. bojan.tepes@siol.net
Telephone: +386-3-8191411 Fax: +386-3-8191412
Received: January 23, 2017
Peer-review started: January 27, 2017
First decision: March 16, 2017
Revised: March 25, 2017
Accepted: June 1, 2017
Article in press: June 1, 2017
Published online: August 28, 2017
Processing time: 217 Days and 1.1 Hours
Peer-review started: January 27, 2017
First decision: March 16, 2017
Revised: March 25, 2017
Accepted: June 1, 2017
Article in press: June 1, 2017
Published online: August 28, 2017
Processing time: 217 Days and 1.1 Hours
Core Tip
Core tip: The urea breath test (UBT) with new test meal Reflex (5.5 g powder mixture of citric, malic and tartaric acid) was tested in one hundred and fourteen consecutive patients with dyspepsia, 53 Helicobacter pylori (H. pylori) positive, 49 H. pylori negative. After being on esomeprazole 40 mg for 29 consecutive days, the 13C-UBT was performed the next morning. The sensitivity of the 13C-UBT (cut off 2.5‰) was 92.45% by per-protocol (PP) analysis and 78.13% by intention-to-treat (ITT) analysis. The specificity of the 13C-UBT test was 96.00% in the ITT population and 97.96% in the PP population.