Enzyme replacement for lactose malabsorption using a beta-D-galactosidase.
We evaluated 10 healthy symptomatic lactose malabsorbers for effect of an oral beta-D-galactosidase derived from Aspergillus oryzae (Lactrase, Kremers Urban Company, Milwaukee, WI, U.S.A.) on symptom and breath hydrogen response to challenge with 50 g lactose. Basally and at 30-min intervals for 8 h after lactose challenge, end-alveolar breath samples were collected and analyzed for hydrogen using gas chromatography. Symptoms were scored at 30 min and hourly for 8 h, rating bloating, cramps, nausea, pain, diarrhea, and flatulence. Four challenges were performed on 4 separate days with at least 3 days between challenges. The first two challenges served as baselines. Just before ingestion of 50 g powdered lactose dissolved in 200 ml water, beta-D-galactosidase capsules were given orally as a 250-mg dose for the third challenge and a 500-mg dose for challenge 4. Hydrogen excretion, quantified by using a trapezoidal method for computing area under the discontinuous curve of breath hydrogen concentration, was decreased in subjects receiving beta-D-galactosidase (base-line I, 346.0 ppm/h; baseline II, 367.2 ppm/h; 250-mg galactosidase 208.2 ppm/h; 500-mg galactosidase, 178.0 ppm/h; p less than or equal to 0.05). Other analyzed parameters of H2 excretion were also decreased. Analysis of symptom response scores showed a dose-related decrease for bloating and flatus (p less than or equal to 0.05) and no statistical difference in the other assessed symptoms. We conclude that beta-D-galactosidase from Aspergillus oryzae, when given just before ingestion of lactose by lactose malabsorbers, can produce a dose-dependent reduction (statistically significant for the 500-mg dose) in breath hydrogen excretion, bloating, and flatus.
DiPalma
J A
JA
University of South Alabama College of Medicine, Division of Gastroenterology, Mobile 36617.
Collins
M S
MS
D000328:Adult; D001944:Breath Tests; D004305:Dose-Response Relationship, Drug; D005260:Female; D005696:Galactosidases / Q000627:therapeutic use*; D006801:Humans; D006859:Hydrogen / Q000032:analysis; D007785:Lactose; D007787:Lactose Intolerance / Q000188:drug therapy*; D007789:Lactose Tolerance Test; D008297:Male; D001616:beta-Galactosidase / Q000627:therapeutic use*
D006859:Hydrogen; D005696:Galactosidases; D001616:beta-Galactosidase; D007785:Lactose