Lactose Intolerance, Hypolactasia
Conditions
Interventions
Experimental group 1:50 experimental group research participants with lactose intolerance will receive oral 5,000 FCC ALU of lactase enzyme in a single dose in the form of 1 chewable tablet on an empt
Other
D08.811.277.450.410.100.500
Sponsors
Nutracom Indústria e Comércio Ltda.
Instituto Claudia Marques de Pesquisa e Desenvolvimento Ltda.
Eligibility
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Volunteers diagnosed with lactose intolerance; Volunteers with genotype CC - not persistent Lactase (intolerance to lactose); Volunteers of both sexes (male or female) aged 18-55 years; BMI between 18.5 and 30 kg / m2; Good health or without significant disease, the medical judgment, in accordance with the rules set out in the protocol; Able to understand the nature and purpose of the study.
Exclusion criteria
Exclusion criteria: Volunteer known to have hypersensitivity reaction known to the study of the product (lactase) or the formulation excipients including lactose; maintenance therapy for use with any drug that interacts with lactase or interferes in the results of the breath test, except for contraceptives; Treatment with laxatives, antibiotics, prokinetic (eg, metoclopramide, domperidone, cisapride and others.), Or any drugs known to influence the colonic flora or gastrointestinal motility in the month prior to the study; Use Vitamins and dietary supplements; History or presence of liver, renal, pulmonary, cardiac, neurological or metabolic diseases; Malignancies; organic gastrointestinal diseases; secondary hypolactasia; reported anemia or proven from the results of laboratory examination of blood count; Giardiasis and strongyloidiasis proven from the results of laboratory parasitological examination of stool; Diabetes reported or confirmed; Hypoglycemia proven from the results of laboratory examination of plasma glucose: below 55 mg / dl for men and 45 mg / dl for women; Diseases which cause damage in the intestinal mucosa, diseases that significantly increase the gastrointestinal transit as infectious enteritis, celiac disease, inflammatory bowel disease (Chron), drug-induced enteritis or radiation, diverticular disease of the colon; History of surgery: heart (whatever), renal (exercises kidney or renal agenesis), intestinal (partial or total removal of the esophagus, stomach, duodenum, jejunum, ileum, ascending colon, transverse colon, descending colon, sigmoid colon or rectum) , liver or pancreas; Volunteers smoking more than five cigarettes a day; different eating habits of the population standard, eg vegetarianism, veganism; History of alcohol consumption or use of drugs of abuse; Made use of antibiotics as regular medication (continuous use) within the 4 weeks preceding the valuation date and / or the start of the breath test; This examination Colonoscopy one month before the breath test H2 expired. After the intestinal flora colonoscopy need to 4 weeks to recover; Use of antiparasitic drugs in the 30 days preceding the breath test H2 expired. Held bowel tests, for which intestinal cleaning was done; Participation in a clinical trial in the last 12 months before the beginning of the study; Diarrhoea on the H2 breath test expired; The volunteer has any condition that prevents him from participating in the study by the judgment of the physician clinical researcher; positive pregnancy test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The variables to be evaluated are the level of H2 over time, symptoms (bloating, abdominal pain and bloating) and diarrhea. Using Lilliefors tests, parametric tests, confidence intervals of 90% in market of normality of variables. In the case of non-normal non-parametric tests for group averages will be realized. For comparisons of means between two groups, Student t test (for parametric) or Mann-Whitney test (for non-parametric) will be realized. | — |
Secondary
| Measure | Time frame |
|---|---|
| The systemic adverse events from lactose intolerance may arise during the conduct of the study. They will be evaluated and reported. | — |
Countries
Brazil
Contacts
Public ContactAlessandra dos Santos
Instituto Claudia Marques de Pesquisa e Desenvolvimento Ltda.
Outcome results
None listed