Effect of exogenousß-galactosidase in patients with lactose malabsorption and intolerance: a crossover double-blind placebo-controlled study.

OBJECTIVE:: To evaluate the efficacy of the addition to milk, 5?min and 10?h before its consumption, of a lactase obtained from Kluyveromyces lactis in lactose malabsorbers with intolerance. DESIGN:: Double-blind, placebo-controlled, crossover study. SETTING:: University Hospital. SUBJECTS:: In total, 11 male and 19 female (aged from 18 to 65?y, mean age 43.3?y) lactose malabsorbers with intolerance participated. INTERVENTIONS:: Each patient underwent three H₂ breath tests, in a random order. We used 400?ml of cow's semiskimmed milk as substrate and aß-galactosidase obtained from K. lactis. The test A was carried out adding to the milk the enzyme (3000?UI), 10?h before its consumption; the test B was performed adding theß-galactosidase (6000?UI) 5?min before milk ingestion and the test C was made using placebo. We evaluated the maximum breath H₂ concentration, the cumulative H₂ excretion and a clinical score based on intolerance symptoms (bloating, abdominal pain, flatulence and diarrhoea). RESULTS:: Our study showed a significant reduction of the mean maximum H₂ concentration after both test A (12.07±7.8?p.p.m.) and test B (13.97±7.99?p.p.m.) compared with test C (51.46±16.12?p.p.m.) (ANOVA F=54.33, P<0.001). Similarly, there was a significant reduction of the mean cumulative H₂ excretion after both test A (1428±1156?p.p.m.) and test B (1761±966?p.p.m.) compared with test C (5795±2707?p.p.m.) (ANOVA F=31.46, P<0.001). We also observed a significant reduction of the mean clinical score after both test A (0.36±0.55) and test B (0.96±0.85) compared with test C (3.7±0.79) (ANOVA F=106.81, P<0.001). Moreover, with regard to the mean clinical score, there was a significant reduction after test A with respect to test B (Bonferroni's P=0.03). CONCLUSIONS:: Our study shows that in lactose malabsorbers with intolerance, the lactase obtained from K. lactis can represent a valid therapeutic strategy, with objective and subjective efficacy and without side effects.European Journal of Clinical Nutrition (2005) 59, 489-493. doi:10.1038/sj.ejcn.1602098 Published online 26 January 2005 [ABSTRACT FROM AUTHOR]