Oral Administration of Exogenous Lactase in Tablets for Patients Diagnosed With Lactose Intolerance Due to Primary Hypolactasia

Abstract

-Background -Primary hypolactasia is a common condition where a reduced lactase activity in the intestinal mucosa is present. The presence of abdominal symptoms due to poor absorption of lactose, which are present in some cases, is a characteristic of lactose intolerance. Objective -Evaluate the efficacy of a product containing exogenous lactase in tablet form compared to a reference product with proven effectiveness in patients with lactose intolerance. Methods -Multicentre, randomized, parallel group, single-blind, comparative non-inferiority study. One hundred twenty-nine (129) adult lactose intolerance patients with hydrogen breath test results consistent with a diagnosis of hypolactasia were randomly assigned to receive the experimental product (Perlatte ® -Eurofarma Laboratórios S.A.) or the reference product (Lactaid ® -McNeilNutritionals, USA) orally (one tablet, three times per day) for 42 consecutive days. Results -Data from 128 patients who actually received the studied treatments were analysed (66 were treated with the experimental product and 62 with the reference product). The two groups presented with similar baseline clinical and demographic data. Mean exhaled hydrogen concentration tested at 90 minutes after the last treatment (Day 42) was significantly lower in the experimental product treated group (17±18 ppm versus 34±47 ppm) in the per protocol population. The difference between the means of the two groups was -17 ppm (95% confidence interval [95% CI]: -31.03; -3.17). The upper limit of the 95% CI did not exceed the a priori non-inferiority limit (7.5 ppm). Secondary efficacy analyses confirmed that the treatments were similar (per protocol and intention to treat population). The tolerability was excellent in both groups, and there were no reports of serious adverse events related to the study treatment. Conclusion -The experimental product was non-inferior to the reference product, indicating that it was an effective replacement therapy for endogenous lactase in lactose intolerance patients. HEADINGS -Lactase. Lactose intolerance. beta-Galactosidase. Clinical trial.

Lactose Intolerance—Old and New Knowledge on Pathophysiological Mechanisms, Diagnosis, and Treatment

“…From the results obtained in the various clinical trials mentioned above, in reference to therapeutic option, it is not possible to define a standardized therapy. This is determined by the fact that the effects obtained by the administration of a certain compound are not always homogeneous, as, for example, in the case of exogenous lactase [40][41][42][43][44]. Instead, we should define a treatment tailored to the patient, evaluating which therapeutic options are most effective for the person in question.…”

“…This enzymatic compound is obtained from yeast (Kluyveromyces lactis) or fungi (Aspergillus oryzae, Aspergillus niger) and it is able to break down lactose into glucose and galactose to allow a better absorption. Administration of exogenous lactase as pills has been used to treat lactose intolerance in children, adolescents, and adults with extremely good results in terms of improving the clinical picture [40,41]. However, not all clinical studies that have been performed to evaluate the efficacy of exogenous lactase have led to satisfactory results.…”

European guideline on indications, performance, and clinical impact of hydrogen and methane breath tests in adult and pediatric patients: European Association for Gastroenterology, Endoscopy and Nutrition, European Society of Neurogastroenterology and Motility, and European Society for Paediatric Gastroenterology Hepatology and Nutrition consensus

“…A well-performed H 2 BT addresses this limitation by detecting malabsorption (H 2 increase above a set diagnostic threshold) and confirming the temporal relationship between this objective event and the occurrence of subjective symptoms. 13,52,83,91,92,[103][104][105] However, there is little evidence on test-retest reliability of H 2 BT, and large variations in breath H 2 response to fructose have been observed…”

Sources of β-galactosidase and its applications in food industry

“…On a commercial scale, bacterial and fungal lactase enzymes are being used to treat milk products. Medicines containing b-galactosidase are also available, which are taken before consuming milk products (Francesconi et al 2016). These medicines possess fungalderived b-galactosidases, usually Aspergillus, that is stable at low pH allowing for the proper functioning in stomach (Panesar et al 2007).…”