RBR-53hjzk招募中3 期
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 个研究点开始时间: 2016年9月9日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Intervention
入排标准
- 年龄范围
- 18Y 至 55Y（—）
入选标准
- •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.
排除标准
- •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.
研究者
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