CTRI/2021/08/035848招募中3 期
A double blind, randomized, parallel group study to evaluate efficacy and safety of Probiotika off capsule against placebo in the treatment of Irritable Bowel Syndrome.
utrin GmbH0 个研究点目标入组 0 人开始时间: 待定最近更新:
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
- Interventional
入排标准
入选标准
- •1. Subjects of either sex
- •2. Age 18 - 65 years (both inclusive)
- •3. Mild to moderate (using Functional Bowel Disorder Severity Index (FBDSI)) IBS: IBS definition will be based on Rome criteria.
- •4. Patient is willing to discontinue any laxatives used before the Pretreatment Visit in favor of the protocol-defined Rescue Medicine (bisacodyl tablets or suppositories).
- •5. Are free of any disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
- •6. If female of childbearing potential, must be willing to practice an acceptable form of birth control for the duration of the study.
- •7. Are able to give written informed consent in a manner approved by the Institutional Ethics Committee and comply with the requirements of the study.
- •8. Are willing to avoid participation in any other interventional clinical trial for the duration of this study.
排除标准
- •1. Are pregnant, breast-feeding, or planning to become pregnant during the study.
- •2. Patients requiring the use of antibiotics either in medicine form of natural (e.g. grapefruit seed extract, olive leaf extract,
- •oil of oregano, colloidal silver and highly concentrated garlic preparations)
- •3. Patients requiring treatments with non permitted medication (i.e. 5-HT3 antagonist, spasmolytics, anticholinergics, cholestyramine, anti-flatulence agents, metoclopramide, gastric-anti secretory agents (proton pump inhibitors; for indications other than Gastroesophageal Reflux Disease (GERD)), narcotics, anti-diarrheal drugs, and systemic
- •4. Patients allergic to milk or soy products
- •5. Patient has a potential central nervous system cause of constipation (e.g., Parkinsonâ??s disease, spinal cord injury, and multiple sclerosis).
- •6. Patient has ever had a fecal impaction that required hospitalization or emergency room treatment, or has a history of cathartic colon, laxative or enema abuse, ischemic colitis,
- •or pelvic floor dysfunction (unless successful treatment has been documented by a normal balloon expulsion test).
- •7. Patient has untreated hypothyroidism or treated hypothyroidism for which the dose of thyroid hormone has not been stable for at least 6 weeks at the time of the
- •8. Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments.
- •9. Have participated in any interventional clinical trial in the previous 30 days.
- •10. Have a known sensitivity to any of the constituents of the test product
- •11. Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including oral or parenteral corticosteroids.
- •12. Have a history of alcohol or illegal drug/substance abuse, or suspected alcohol or illegal drug/substance abuse in the past
研究者
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