title: Effect of exogenous beta-galactosidase in patients with lactose malabsorption and intolerance: a crossover double-blind placebo-controlled study.
abstract: 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.
  
  
  METHODS
  Double-blind, placebo-controlled, crossover study.
  
  
  METHODS
  University Hospital.
  
  
  METHODS
  In total, 11 male and 19 female (aged from 18 to 65 y, mean age 43.3 y) lactose malabsorbers with intolerance participated.
  
  
  METHODS
  Each patient underwent three H(2) breath tests, in a random order. We used 400 ml of cow's semiskimmed milk as substrate and a beta-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 the beta-galactosidase (6000 UI) 5 min before milk ingestion and the test C was made using placebo. We evaluated the maximum breath H(2) concentration, the cumulative H(2) 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 H(2) 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 H(2) 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.
authors.affiliation: Institute of Internal Medicine, Catholic University, 00168 Rome, Italy. mmontalto@rm.unicatt.it
authors.forename: M
authors.initials: M
authors.lastname: Montalto
authors.forename: G
authors.initials: G
authors.lastname: Nucera
authors.forename: L
authors.initials: L
authors.lastname: Santoro
authors.forename: V
authors.initials: V
authors.lastname: Curigliano
authors.forename: M
authors.initials: M
authors.lastname: Vastola
authors.forename: M
authors.initials: M
authors.lastname: Covino
authors.forename: L
authors.initials: L
authors.lastname: Cuoco
authors.forename: R
authors.initials: R
authors.lastname: Manna
authors.forename: A
authors.initials: A
authors.lastname: Gasbarrini
authors.forename: G
authors.initials: G
authors.lastname: Gasbarrini
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000818:Animals; D001944:Breath Tests; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007716:Kluyveromyces / Q000201:enzymology; D007787:Lactose Intolerance / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D008892:Milk / Q000201:enzymology; D013997:Time Factors; D016896:Treatment Outcome; D001616:beta-Galactosidase / Q000494:pharmacology*
chemical_list: D001616:beta-Galactosidase