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.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Nutrin GmbH
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Comparison of the abdominal
研究概览
简要总结
Irritable bowel syndrome (IBS) is a chronic functional gastrointestinal (GI) disorder characterized by recurrent symptoms of abdominal pain and/or discomfort, accompanied by altered bowel function and a feeling of bloating, moderate to severe cases of IBS, an overall deterioration in quality of life (QOL) is often present. An altered gut brain axis has been the main pathogenetic mechanism of IBS, which is associated with GI autonomic nervous system. These alterations may lead to abnormal visceral hypersensitivity and contribute to the symptoms. Gut microbiota plays important role in the maintenance of gut homeostasis by direct bactericidal effect and the evolution of both innate and adaptive immune system. Gut microbiota plays important role in pathogenesis of IBS. This is evident from the fact that IBS occurs more frequently after intestinal infections and antibiotic treatment. Studies have shown the alterations of the intestinal microbiota. Considering the relationship between gut microbiota and inflammation of gut, manipulation of gut microbiota by probiotics appears to be an ideal treatment modality for IBS.
Probiotika off is a medical device which is for use in patients with irritable bowel syndrome. It is intended to relieve the symptoms and pain. Probiotika off is used to treat symptoms of irritable bowel syndrome. Patients suffering from this disease often suffer from urge to defecate, diarrhoea, bloating, flatulence, abdominal pain or constipation. One capsule contains 100 mg Heat-Inactivated Lactobacillus Acidophilus. The maximum daily dose is one capsule. In accordance with the Medical Device Directive 93/42/EEC, it is recommended that after 30 days of use of the medical device, a break of 3-5 days is observed. Probiotika off is a medical device in the form of capsules containing heat-inactivated Lactobacillus acidophilus. Its mode of action is to inhibit the attachment of pathogens to the wall of the gastrointestinal tract. Pathogenic bacteria in the gastrointestinal tract must attach themselves to the wall of the intestine to develop disease syndromes; if heat-inactivated probiotic cells effectively compete with the pathogens for binding sites, the virulence of the pathogens would be reduced.
Heat-treated probiotic cells are able to
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Protection against enteropathogens
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Maintaining the integrity of the intestinal barrier
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Competition for resources
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Elimination of competition through competition for binding sites
Symptoms caused by irritable bowel syndrome can thus be relieved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of either sex
- •65 years (both inclusive)
- •Mild to moderate (using Functional Bowel Disorder Severity Index (FBDSI)) IBS: IBS definition will be based on Rome criteria.
- •Patient is willing to discontinue any laxatives used before the Pretreatment Visit in favor of the protocol-defined Rescue Medicine (bisacodyl tablets or suppositories).
- •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.
- •If female of childbearing potential, must be willing to practice an acceptable form of birth control for the duration of the study.
- •Are able to give written informed consent in a manner approved by the Institutional Ethics Committee and comply with the requirements of the study.
- •Are willing to avoid participation in any other interventional clinical trial for the duration of this study.
排除标准
- •Are pregnant, breast-feeding, or planning to become pregnant during the study.
- •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)
- •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 steroids)
- •Patients allergic to milk or soy products
- •Patient has a potential central nervous system cause of constipation (e.g., Parkinson’s disease, spinal cord injury, and multiple sclerosis).
- •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).
- •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 Screening.
- •Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments.
- •Have participated in any interventional clinical trial in the previous 30 days.
- •Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including oral or parenteral corticosteroids.
- •Have a history of alcohol or illegal drug/substance abuse, or suspected alcohol or illegal drug/substance abuse in the past 2 years.
结局指标
主要结局
Comparison of the abdominal
时间窗: Baseline to Day 30
pain relief and changes in stool frequency before and after the treatment, between the two arms.
时间窗: Baseline to Day 30
次要结局
- The defecation component of the primary end point will be evaluated by “Bristol stool form scaleâ€.(Baseline and Day 30)
- Abdominal pain component of the primary end point will be accessed by using an 10 point numeric rating scale that asks patient daily to rate their abdominal pain over the past 24 hours.(Baseline and Day 30)
- quality-of-life parameter as measured by IBSSSS before and after treatments, between 2 arms(Baseline and Day 30)
- quality-of-life parameter as measured by EQ5D before and after treatments, between 2 arms(Baseline and Day 30)
- quality-of-life parameter as measured by SF12v2 before and after treatments, between 2 arms(Baseline and Day 30)