Original Communication
European Journal of Clinical Nutrition (2005) 59, 489–493. doi:10.1038/sj.ejcn.1602098 Published online 26 January 2005 doi:1602098A/sj.bjp.0704832
Effect of exogenous 
-galactosidase in patients with lactose malabsorption and intolerance: a crossover double-blind placebo-controlled study
Guarantor: M Montalto.
Contributors: MM designed the study, wrote the manuscript and recruited the patients with the help of GN. LS, VC, MV, LC, RM, AG and GG participated in clinical assessment, data management and editing of the paper. MC carried out statistical calculations. All authors reviewed the manuscript and approved the final version.
M Montalto1, G Nucera1, L Santoro1, V Curigliano1, M Vastola1, M Covino1, L Cuoco1, R Manna1, A Gasbarrini1 and G Gasbarrini1
1Institute of Internal Medicine, Catholic University, Rome, Italy
Correspondence: M Montalto, Istituto di Medicina Interna, Università Cattolica del Sacro Cuore, Policlinico 'A.Gemelli', Largo Gemelli, 8, 00168 Rome, Italy. E-mail: mmontalto@rm.unicatt.it
Received 10 March 2004; Revised 27 July 2004; Accepted 25 October 2004; Published online 26 January 2005.
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.
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 a 
-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 -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 (13.977.99 p.p.m.) compared with test C (51.4616.12 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 (14281156 p.p.m.) and test B (1761966 p.p.m.) compared with test C (57952707 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 (0.360.55) and test B (0.960.85) compared with test C (3.70.79) (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.
Keywords:
lactose malabsorption, lactose intolerance, enzyme replacement, -galactosidase, Kluyveromyces lactis
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