β-Galactosidase from Aspergillus niger in adult lactose malabsorption: A double-blind crossover study

An assessment was made of the efficacy of a β-galactosidase, obtained from Aspergillus niger and added to intact milk, in decreasing lactose malabsorption and intolerance. Sixteen adult patients with malabsorption and intolerance to this sugar were studied in a double-blind crossover study vs. placebo. A 5-hour hydrogen breath test was used to assess malabsorption of lactose contained in 400 ml milk. When compared with placebo, the addition of exogenous lactase to intact milk caused a statistically significant reduction in the maximum breath H ₂ concentration (P <0.01) and in the cumulative H ₂ excretion (P <0.005). In the same way, the cumulative index for gastrointestinal intolerance was significantly lower (P <0.005) after the ingestion of lactase-added milk. This study demonstrates that enzyme replacement therapy, with β-galactosidases obtained from Aspergillus niger, is effective in decreasing lactose malabsorption and its consequent intolerance in adult subjects with lactase deficiency.