EUCTR2007-004127-38-IT进行中(未招募)不适用
SE OF ORAL TILACTASE ENZYMES IN SUBJECTS WITH LACTOSE MALABSORPTION AND INTOLERANCE. CLINICAL RELEVANCE IN A POPULATION WITH HIGH PREVALENCE OF LACTASE DEFICIENCY IN SOUTHERN ITALY. - TILATT/0708
AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE0 个研究点开始时间: 2012年1月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects with persisting symptoms (i.e. longer than 6 months) located either in the upper and/or lower abdomen suggestive of lactose intolerance, fructose intolerance, small intestinal bacterial overgrowth (SIBO), functional gastrointestinal disorders (i.e. irritable bowel, functional dyspepsia, functional diarrhea)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects with alarm symptoms (e.g. anaemia, unexplained weight loss, chronic pain, ineffective therapies) or older than 50 years will be further investigated with upper a/o lower endoscopy and blood tests in order to rule out inflammatory bowel diseases, celiac disease, intestinal neoplasms, colonic diverticula, and thyroid diseases. If needed, patients will undergo Rx barium enema for characterization of colonic diverticula and severe dolicocolon, as a potential cause of lower intestinal symptoms. Excluded from the study will be also non-compliant subjects or those with an history of liver, renal, lung, heart, metabolic, or neurological disease and those taking laxatives, antibiotics, prokinetics, or any other drug known to influence colonic flora or gastrointestinal motility in the month preceding the study. All patients with known causes of secondary osteoporosis other than lactose intolerance will be not included in the soubgroup evaluating bone markers.
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