Diferent doses of lactase in subjects with intolerance lactose

Phase 3

Recruiting

• Conditions: actose Intolerance, Hypolactasia

• Registration Number: RBR-53hjzk
• Lead Sponsor: utracom Indústria e Comércio Ltda.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-09
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified