NCT02746198已完成不适用
A Randomized Double-blind Placebo-controlled Clinical Pilot Trial on the Effect of a Probiotic Fermented Drink on Antibiotic-associated Diarrhea (AAD) in Patients With Helicobacter Pylori Eradication Therapy
Clinical Research Center Kiel GmbH2 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2016年1月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Occurrence of antibiotic-associated diarrhea (AAD)
研究概览
简要总结
The aim of the study is to estimate the effect of a probiotic dairy drink on occurrence and duration of AAD and gastrointestinal symptoms during Helicobacter pylori (Hp) eradication therapy and during 4 weeks thereafter and calculating the sample size for a confirmatory study.
详细描述
Helicobacter p. positive subjects aged ≥18 years with an indication for Helicobacter pylori (Hp) eradication recommended by a gastroenterologist should be included in the study. Subjects should be willing to consume 2 servings of the study product per day for 6 weeks, and to undergo an Hp eradication therapy for 14 days starting with the consumption period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals, both genders, aged ≥ 18 y
- •Helicobacter p. infected individuals, to which eradication therapy has been recommended by gastroenterologists
- •Willingness to undergo the Helicobacter p. eradication therapy
- •Willingness to abstain from food and supplements containing probiotics, prebiotics and fermented products except the study product
- •Written informed consent
排除标准
- •Subjects currently enrolled in another interventional trial
- •subjects having finished another interventional trial within the last 4 weeks before inclusion
- •incapacity to comply with the study protocol
- •allergy or hypersensitivity to any component of the test product (allergy against milk protein)
- •allergy or hypersensitivity to any component of the eradication therapy (e.g. penicillin allergy)
- •acute GIT infections
- •chronic inflammatory bowel diseases (IBD)
- •irritable bowel syndrome (IBS)
- •any episode of diarrhea according to WHO criteria during the last 4 weeks before inclusion
- •history of lactose intolerance
- •severe chronic disease (cancer, malabsorption, malnutrition, severe chronic inflammatory diseases (except chronic gastritis), renal, hepatic or cardiac diseases, artificial cardiac valve, COPD, respiratory insufficiency)
- •history of active or persistent hepatitis B and C
- •known congenital, acquired or iatrogenic immunodeficiency (e.g. HIV, chemotherapy, immunosuppression)
- •systemic treatment with antibiotics during the last 4 weeks before inclusion
- •systemic treatment likely influencing absorption, metabolism and excretion of food ingredients (metoclopramide, laxatives, body weight management and/or medication etc.)
- •systemic treatment likely interfering or influencing effectiveness of the eradication drugs used e.g. ergotamine, statins, clopidogrel
- •regular medical treatment including OTC, which may have impact on the study aims (e.g. probiotics, antibiotic drugs, laxatives etc.)
- •severe neurological, cognitive or psychiatric diseases
- •surgery or intervention requiring general anaesthesia within 2 months before the study
- •eating disorders (e.g. anorexia, bulimia)
- •present alcohol and drug abuse
- •pregnancy or lactation
- •legal incapacity
- •blood parameters:
- •Hb < 12 g/dL
- •liver transaminases (ALT, AST) > 2-fold increased
- •serum creatinine out of the normal range
- •subjects who are scheduled to undergo hospitalization during the study period
结局指标
主要结局
Occurrence of antibiotic-associated diarrhea (AAD)
时间窗: 6 weeks
Occurrence of antibiotic-associated diarrhea (AAD) (as defined by number of subjects with diarrhea within the intervention period of 6 weeks after starting antibiotic treatment; diarrhea is defined according WHO
次要结局
- Cumulative sverity of antibiotic-associated diarrhea (AAD)(6 weeks)
- Gastrointestinal Symptom Rating Scale(6 weeks)
- Cumulated duration of antibiotic-associated diarrhea (AAD)(6 weeks)
研究者
研究点 (2)
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