RPCEC00000294尚未招募3 期
Phase III clinical trial, prospective randomized, of superiority, to evaluate the efficacy and safety of Colilen IBS vs. placebo in Irritable Bowel Syndrome. Batch comparability study.
Aboca SpA Società Agricola laboratories0 个研究点目标入组 140 人开始时间: 2018年11月28日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 19 years 至 80 years（—）
- 性别
- All
入选标准
- •1. Patient aged between 19 and 80 years, both inclusive.
- •2. Patient who express their consent to participate in the study in writing.
- •3. Patient with a value of the IBS-SS questionnaire = 175.
排除标准
- •1. Patient with hypersensitivity or individual allergy to one or more components of the formulation.
- •2. Patient with a diagnosis of malignancy, heart failure, severe lung disease or infectious disease.
- •3. Patient who has at least one of the following symptoms or illnesses:
- •- Anemia given by hemoglobin levels below 110 g / L or 11 g / dL.
- •- Chronic digestive hemorrhage.
- •- Progressive loss of involuntary weight given by a loss of at least 10% of body weight in six months or 5% in the last month.
- •- Anorexia nervosa.
- •- Cyclical vomiting that compromises the hydromineral balance or does not allow or prevent proper nutrition or treatment.
- •- Cachexia.
- •4. Patient with involvement in renal and hepatic function, given by:
- •- Kidney function: Creatinine with values outside the normal limits established in the laboratory of the institution.
- •- Liver function: Transaminases (TGP and TGO) with values higher than twice the value of the normal upper limit established in the laboratory of the institution.
- •5. Obese patient (BMI=30).
- •6. Patient with mental disorders that could limit adherence to the requirements of the clinical trial and may hinder the collection of information, treatment or follow-up.
- •7. Pregnant or lactating woman.
- •8. Patient with reproductive and sexually active capacity who does not accept to use at least one contraceptive method.
- •9. Patient diagnosed with chronic pancreatitis.
- •10. Patient with decompensated intercurrent diseases that, at the discretion of the physician, could endanger the safety of the patient and / or compliance with the study procedures by the patient, such as: metabolic, electrolyte or other disorders.
- •11.Patient who requires starting treatment with antidepressants and / or steroids.
- •12. Patient who received treatment with antibiotics and / or steroids in the month prior to inclusion in the study.
- •13. Patient who in the two weeks prior to inclusion in the study received treatment with drugs not allowed as concomitant therapies.
- •14. Patient who consumes probiotic yogurt.
研究者
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