Effect of exogenous β-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. 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 b-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 b-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 (12.0777.8 p.p.m.) and test B (13.9777.99 p.p.m.) compared with test C (51.46716.12 p.p.m.) (ANOVA F ¼ 54.33, Po0.001). Similarly, there was a significant reduction of the mean cumulative H 2 excretion after both test A (142871156 p.p.m.) and test B (17617966 p.p.m.) compared with test C (579572707 p.p.m.) (ANOVA F ¼ 31.46, Po0.001). We also observed a significant reduction of the mean clinical score after both test A (0.3670.55) and test B (0.9670.85) compared with test C (3.770.79) (ANOVA F ¼ 106.81, Po0.001). Moreover, with regard to the mean clinical score, there was a significant reduction after test A with respect to test B (Bonferroni's P ¼ 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.

Probiotics—From Metchnikoff to bioactives

“…Numerous studies have shown that individuals with hypolactasia could tolerate fermented dairy products better than an equivalent quantity in milk (Hertzler & Clancy, 2003;Montalto et al, 2005;Vesa et al, 1996). Various explanations have been suggested in order to clarify this phenomenon.…”

Nano-coating of β-galactosidase onto the Surface of Lactose by Using an Ultrasound-assisted Technique

“…Secondly, a precise method exists for the determination of the substrate/product concentration of β-galactosidase, and consequently, the amount of enzyme. The method is well standardized since the quantitative estimation of lactose in dairy products is a common procedure due to the large number of people with lactose intolerance (22)(23)(24). Thirdly, to prove that the surface-modified powder remains dry and no degradation product appeared as an enzymatic reaction requires water.…”

Lactose Intolerance: Common Misunderstandings

“…However, more data regarding the efficacy of this microbial exogenous enzyme are needed [37]. Other evidence suggested that efficacy of exogenous lactase was obtained from Kluyveromyces lactis , Aspergillus oryzae , or Kluyveromyces lactis [38, 39]. Another strategy involves probiotics that could shape gut microbiota composition.…”