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©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
Four-sample lactose hydrogen breath test for diagnosis of lactose malabsorption in irritable bowel syndrome patients with diarrhea
Jian-Feng Yang, Mark Fox, Hua Chu, Xia Zheng, Yan-Qin Long, Daniel Pohl, Michael Fried, Ning Dai
Jian-Feng Yang, Department of Gastroenterology, The First People’s Hospital of Hangzhou, Hangzhou 310016, Zhejiang Province, China
Mark Fox, Daniel Pohl, Michael Fried, Division of Gastroenterology and Hepatology, University Hospital Zürich, 8006 Zürich, Switzerland
Mark Fox, NIHR Nottingham Digestive Diseases Biomedical Research Unit, Queen’s Medical Centre, Nottingham NG7 2UH, United Kingdom
Jian-Feng Yang, Hua Chu, Xia Zheng, Yan-Qin Long, Ning Dai, Department of Gastroenterology, Sir Run Run Shaw Hospital affiliated to College of Medicine, Zhejiang University, Hangzhou 310016, Zhejiang Province, China
Author contributions: Yang JF performed the study, analyzed the results and drafted the article; Fox M and Pohl D contributed to the design of the study, analyzed the results and edited the manuscript; Chu H, Zheng X and Long YQ provided essential patient support and performed the lactose HBT tests; Fried M contributed to the design of the study and edited the manuscript; Dai N contributed to the design of the study, oversaw the conduct of the study and edited the manuscript; all authors had access to the study data and have reviewed and approved the final version of the article.
Supported by Nestle Research International and The Science and Technology Department of Zhejiang Province, No. 2009C14016.
Ethics approval: The study was approved by the ethical committee of Sir Run Run Shaw Hospital (Reference number 20070823-2) and all participants signed consent for study procedures.
Clinical trial registration: This study is registered at https://clinicaltrials.gov/. The registration identification number is NCT01286597.
Informed consent: All study participants provided informed written consent prior to study enrollment.
Conflict-of-interest: No potential competing interests.
Data sharing: No additional data are 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: Dr. Ning Dai, Department of Gastroenterology, Sir Run Run Shaw Hospital affiliated to College of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou 310016, Zhejiang Province, China.
dainingcn2014@163.com
Telephone: +86-571-86096182 Fax: +86-571-86044817
Received: January 6, 2015
Peer-review started: January 7, 2015
First decision: January 22, 2015
Revised: February 20, 2015
Accepted: March 30, 2015
Article in press: March 31, 2015
Published online: June 28, 2015
Processing time: 173 Days and 16.6 Hours
AIM: To validate 4-sample lactose hydrogen breath testing (4SLHBT) compared to standard 13-sample LHBT in the clinical setting.
METHODS: Irritable bowel syndrome patients with diarrhea (IBS-D) and healthy volunteers (HVs) were enrolled and received a 10 g, 20 g, or 40 g dose lactose hydrogen breath test (LHBT) in a randomized, double-blinded, controlled trial. The lactase gene promoter region was sequenced. Breath samples and symptoms were acquired at baseline and every 15 min for 3 h (13 measurements). The detection rates of lactose malabsorption (LM) and lactose intolerance (LI) for a 4SLHBT that acquired four measurements at 0, 90, 120, and 180 min from the same data set were compared with the results of standard LHBT.
RESULTS: Sixty IBS-D patients and 60 HVs were studied. The genotype in all participants was C/C-13910. LM and LI detection rates increased with lactose dose from 10 g, 20 g to 40 g in both groups (P < 0.001). 4SLHBT showed excellent diagnostic concordance with standard LHBT (97%-100%, Kappa 0.815-0.942) with high sensitivity (90%-100%) and specificity (100%) at all three lactose doses in both groups.
CONCLUSION: Reducing the number of measurements from 13 to 4 samples did not significantly impact on the accuracy of LHBT in health and IBS-D. 4SLHBT is a valid test for assessment of LM and LI in clinical practice.
Core tip: Lactose hydrogen breath test (LHBT) is the preferred method for clinical diagnosis of lactose malabsorption (LM) and lactose intolerance (LI); however, repeated measurements are time consuming and require dedicated personnel. In our study, we found 4-sample LHBT has a high level of agreement with standard 13-breath sample for the clinical diagnosis of LM and LI. The 4SLHBT is a valid replacement for standard LHBT in clinical practice.
