Beneficial effects of oral tilactase on patients with hypolactasia

Background: A lactose-free diet is commonly prescribed to subjects with hypolactasia. We tested the effectiveness of a single ingestion of tilactase (a β-d-galactosidase from Aspergillus oryzae) in adults with hypolactasia, previously assessed by lactose H₂-breath test. Materials and methods: After measurement of orocecal transit time (OCTT, by lactulose H ₂-breath test) and lactose H₂-breath testing plus placebo, a total of 134 subjects were positive to hypolactasia and underwent lactose H₂-breath testing plus either low (6750 U) or standard (11 250 U) doses of tilactase. The appearance of gastrointestinal symptoms during the tests was monitored. Results: OCTT was longer in malabsorbers (subjects without bloating, abdominal pain and/or diarrhoea, n = 25) than in intolerants (bloating, abdominal pain and/or diarrhoea, n = 109, P < 0.02). Malabsorbers had longer time to H₂ peak (P < 0.03), lower H₂ peak levels (P < 0.002) and smaller integrated H₂ excretion levels (P < 0.005) than intolerants. After tilactase ingestion, integrated H ₂ levels were decreased by 75% (low dose) and 87% (standard dose) in malabsorbers, and by 74% (low dose) and 88% (standard dose) in intolerants. In the latter group, total symptom score were decreased by 76% (low dose) and by 88% (standard dose) (P < 0.0001). Conclusion: A single oral administration of tilactase is highly effective in decreasing symptoms and hydrogen excretion of hypolactasia assessed by lactose H₂-breath test. If confirmed by long-term observations, ingestion of tilactase might be a better option than exclusion diets in intolerant subjects with hypolactasia.