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

AbstractOBJECTIVE:
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 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.
AuthorsM Montalto, G Nucera, L Santoro, V Curigliano, M Vastola, M Covino, L Cuoco, R Manna, A Gasbarrini, G Gasbarrini
JournalEuropean journal of clinical nutrition (Eur J Clin Nutr) Vol. 59 Issue 4 Pg. 489-93 (Apr 2005) ISSN: 0954-3007 [Print] England
PMID15674309 (Publication Type: Clinical Trial, Journal Article)
Chemical References
  • beta-Galactosidase
Topics
  • Adolescent
  • Adult
  • Aged
  • Analysis of Variance
  • Animals
  • Breath Tests
  • Cross-Over Studies
  • Double-Blind Method
  • Female
  • Humans
  • Kluyveromyces (enzymology)
  • Lactose Intolerance (drug therapy)
  • Male
  • Middle Aged
  • Milk (enzymology)
  • Time Factors
  • Treatment Outcome
  • beta-Galactosidase (pharmacology)

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