title: ORAL ADMINISTRATION OF EXOGENOUS LACTASE IN TABLETS FOR PATIENTS DIAGNOSED WITH LACTOSE INTOLERANCE DUE TO PRIMARY HYPOLACTASIA.
abstract: 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.
  
  
  
  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.
  
  
  
  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(r) - Eurofarma Laboratórios S.A.) or the reference product (Lactaid(r) - McNeilNutritionals, USA) orally (one tablet, three times per day) for 42 consecutive days.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Hospital de Clínicas de Porto Alegre, RS, Brasil.
authors.forename: Carlos Fernando de Magalhães
authors.initials: CF
authors.lastname: Francesconi
authors.affiliation: Hospital São Lucas, Porto Alegre, RS, Brasil.
authors.forename: Marta Brenner
authors.initials: MB
authors.lastname: Machado
authors.affiliation: Hospital Israelita Albert Einstein, São Paulo, SP, Brasil.
authors.forename: Flavio
authors.initials: F
authors.lastname: Steinwurz
authors.affiliation: Hospital Nossa Senhora das Graças, Curitiba, PR, Brasil.
authors.forename: Rodrigo Bremer
authors.initials: RB
authors.lastname: Nones
authors.affiliation: Unidade Integrada de Gastroenterologia, Campinas, SP, Brasil.
authors.forename: Flávio Antonio
authors.initials: FA
authors.lastname: Quilici
authors.affiliation: Faculdade de Medicina do ABC, Santo André, SP, Brasil.
authors.forename: Wilson Roberto
authors.initials: WR
authors.lastname: Catapani
authors.affiliation: Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brasil.
authors.forename: Sender Jankiel
authors.initials: SJ
authors.lastname: Miszputen
authors.affiliation: Instituto Goiano de Gastroenterologia, Goiânia, GO, Brasil.
authors.forename: Mauro
authors.initials: M
authors.lastname: Bafutto
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D005260:Female; D006801:Humans; D006859:Hydrogen / Q000032:analysis; D043322:Lactase / Q000008:administration & dosage* / Q000172:deficiency*; D007785:Lactose / Q000378:metabolism; D007787:Lactose Intolerance / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016037:Single-Blind Method; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D006859:Hydrogen; D043322:Lactase; D007785:Lactose