EUCTR2009-017874-20-DE进行中（未招募）不适用
Treatment of Diarrhea-predominant Irritable Bowel Syndrome with LACTEOL 340 mg : a pilot study evaluating safety and efficacy
AXCAN PHARMA INC0 个研究点目标入组 60 人开始时间: 2010年3月30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
- 入组人数
- 60
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
- •1. Men or non-pregnant, non nursing women, 18 years of age or above.
- •Women of childbearing potential will need to use a medically
- •acceptable contraceptive regimen (systemic contraceptive,
- •intrauterine/intravaginal method or barrier method)
- •2. Subjects must meet the Rome III Diagnostic Questionnaire for IBS
- •3. Subjects having an IBS Symptom Severity Scale (IBS-SSS) score ranging between 100 and 400
- •4. Subjects having an average Bristol Stool Form Scale score exceeding two (>2) but less than seven (<7)
- •5. Subject is on a stable diet (no drastic lifestyle changes in the quantity and nature of food) for the duration of the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •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
- •1. Diagnosis of Inflammatory Bowel Disease (IBD)
- •2. Chronic use of systemic steroids (on more than 7 consecutive days) in the month prior to screening
- •3. Presence of Type 1 or Type 2 diabetes mellitus
- •4. Suffering from a major psychiatric disorder within the past 2 years prior to screening
- •5. Diagnosis of autoimmune diseases or disorders (ex: Rheumatoid arthritis, Celiac disease, Multiple sclerosis)
- •6. Had undergone any invasive abdominal surgery, with the exception of hernia repair or appendectomy or cholecystectomy
- •7. Presence of current or recent ( within 1 month prior to screening) hematemesis, melena or documented gastrointestinal bleeding or iron-deficiency anemia of clinical signifiance
- •8. Presence of malignant disease of any kind except for successfully treated skin cancer (basal or squamous cell) or any radiation therapy during the previous 5 years prior to screening
- •9. Use of antibiotics within 30 days prior to screening
- •10. Use of any experimental drug within 30 days prior to screening
- •11. Allergy to active substance or any other ingredient in LACTEOL 340mg
- •12. Congenital galactosemia, glucose, fructose and/or galactose malabsorption syndrome, lactase deficiency or lactose intolerance
- •13. Diagnosis of exocrine pancreatic insufficiency
研究者
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