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 H₂‐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 H₂ 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.