The effect of oral supplementation with Lactobacillus reuteri or tilactase in lactose intolerant patients: randomized trial

Eur Rev Med Pharmacol Sci. 2010 Mar;14(3):163-70.


Background: Lactase enzyme supplements and probiotics with high beta-galactosidase activity may be valid treatment options for the lactose intolerance. Aim of this study was to assess whether supplementation with tilactase or Lactobacillus reuteri when compared to placebo affects hydrogen breath excretion and gastrointestinal symptoms in lactose intolerant patients during lactose breath test (H,-LBT).

Methods: Sixty lactose intolerant patients participated in the study and were randomized to three 20 patients-treatment groups: tilactase group (tilactase 15 minutes before control H2-LBT); placebo group (placebo 15 minutes before control H2-LBT); Lactobacillus reuteri group (LR) (LR b.i.d. during 10 days before control H2-LBT). The outcomes were LBT normalization rate, and influences of treatments on both mean maximum hydrogen concentration and clinical score.

Results: LBT normalization rate was significantly higher in tilactase and LR groups with respect to placebo. Tilactase was significantly more effective than LR in achieving LBT normalization (p <0.01). Both significant reduction of mean peak H2 excretion and improvement of the mean clinical score were observed in tilactase and LR groups after treatment with respect to placebo (p <0.0001). Tilactase was significantly more effective than LR in reducing both mean peak hydrogen excretion and mean clinical score.

Conclusions: In lactose intolerants, tilactase strongly improves both LBT results and gastrointestinal symptoms after lactose ingestion with respect to placebo. Lactobacillus reuteri also is effective but lesser than tilactase. This probiotic may represent an interesting treatment option for lactose intolerance since its use is simple and its effect may last in the time after stopping administration.

Publication types

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

MeSH terms

  • Abdominal Pain / enzymology
  • Abdominal Pain / microbiology
  • Abdominal Pain / therapy
  • Administration, Oral
  • Adult
  • Breath Tests
  • Diarrhea / enzymology
  • Diarrhea / microbiology
  • Diarrhea / therapy
  • Female
  • Flatulence / enzymology
  • Flatulence / microbiology
  • Flatulence / therapy
  • Hormone Replacement Therapy*
  • Humans
  • Lactase / administration & dosage*
  • Lactose / administration & dosage
  • Lactose Intolerance / complications
  • Lactose Intolerance / enzymology
  • Lactose Intolerance / microbiology
  • Lactose Intolerance / therapy*
  • Limosilactobacillus reuteri / enzymology*
  • Male
  • Pain Measurement
  • Probiotics / administration & dosage*
  • Prospective Studies
  • Time Factors
  • Treatment Outcome
  • beta-Galactosidase / metabolism*


  • Lactase
  • beta-Galactosidase
  • Lactose