Four-sample lactose hydrogen breath test for diagnosis of lactose malabsorption in irritable bowel syndrome patients with diarrhea

World J Gastroenterol. 2015 Jun 28;21(24):7563-70. doi: 10.3748/wjg.v21.i24.7563.


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.

Trial registration: NCT01286597.

Keywords: Diagnosis; Irritable bowel syndrome; Lactose hydrogen breath test; Lactose intolerance; Lactose malabsorption.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Biomarkers / metabolism
  • Breath Tests*
  • China
  • Cross-Over Studies
  • Diarrhea / diagnosis
  • Diarrhea / etiology*
  • Double-Blind Method
  • Genetic Predisposition to Disease
  • Humans
  • Hydrogen / metabolism*
  • Irritable Bowel Syndrome / complications*
  • Irritable Bowel Syndrome / diagnosis
  • Lactase / deficiency
  • Lactase / genetics
  • Lactose / administration & dosage
  • Lactose / metabolism*
  • Lactose Intolerance / complications
  • Lactose Intolerance / diagnosis*
  • Lactose Intolerance / genetics
  • Lactose Intolerance / metabolism
  • Polymorphism, Single Nucleotide
  • Predictive Value of Tests
  • Promoter Regions, Genetic
  • Reproducibility of Results
  • Time Factors


  • Biomarkers
  • Hydrogen
  • Lactase
  • Lactose

Associated data