RBR-53hjzk
Recruiting
Phase 3
Clinical trial for the evaluation of the efficacy and safety of lactase different oral dosages upon intestinal symptoms and hydrogen breath excretion in patients with hypolactasia
utracom Indústria e Comércio Ltda.0 sitesSeptember 9, 2016
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- utracom Indústria e Comércio Ltda.
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
Testing a food supplement in improving strength, power and mental alertnessHealthy volunteerNot ApplicableISRCTN86507492Farmaceutici Procemsa S.p.A.60
Active, not recruiting
Phase 2
Study on efficacy of herbal drugs in reducing viral load in HIV/AIDS patientsCTRI/2022/09/045548MVR Ayurveda medical college
Active, not recruiting
Not Applicable
The effectiveness and safety of oral adhesive bandage for extraction wound managementWound management in tooth extractionOral HealthISRCTN11589028Wuhan University120
Recruiting
Phase 3
Thalidomide effects in COVID-19Covid 19.Covid 19IRCT20110423006257N3Arak University of Medical Sciences66
Completed
Not Applicable
Probiotics clinical trials on allergic rhinitisKCT0002661VP Healthcare80