The Effect of Jarro-Dophilus EPS Probiotics on the Prevention of Diarrhea, Quality of Life and Symptoms in Adults Receiving Antibiotic Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- Incidence of patients experiencing diarrhea
研究概览
简要总结
The purpose of this study is to evaluate if ingestion of a probiotic formula (Jarrow-Dophilus EPS)reduces incidence of diarrhea and improves the quality of life of patients receiving antibiotic therapy.
详细描述
A common complication of antibiotic use is antibiotic-induced diarrhea (AAD). AAD is the result of disrupted microflora, occurring two to eight weeks after antibiotic use. Probiotic supplementation may rebalance the intestinal flora, thus reducing the incidence of diarrhea, improving quality of life and reducing symptoms associated with antibiotic administration.
The proposed study will be a prospective, randomized, double blind, placebo-controlled trial that will assess the efficacy of the Jarro-Dophilus EPS probiotics formula for the prevention of AAD.
In addition,a subgroup of participants will be requested to provide one fecal sample at the initiation of the study and one sample in the last three days of probiotic (or placebo) treatment. The samples will undergo microbial analysis for routine C & S(Salmonella, Shigella, Campylobacter, Ecoli 0157, Yersinia), VRE, Yeast, Fungus culture (moulds) and C. difficile toxin.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years of age
- •Prescribed oral or IV antibiotics by physicians in Saskatoon Health Region's community medical clinics
排除标准
- •Treatment with an antibiotic two weeks prior to study entry
- •Underlying long term gastrointestinal disease (i.e., Ulcerative Colitis, Crohn's Disease, irritable bowel syndrome, ileostomy, colostomy)
- •Pregnant or lactating
- •Immunocompromised state
- •Chronic illness such as Hepatitis B, Hepatitis C, renal failure
- •Inability to provide informed consent, inability to speak or write in English
- •Receiving tube feeds
- •Insufficiently functional (physically and cognitively) to complete the study diary and questionnaires.
结局指标
主要结局
Incidence of patients experiencing diarrhea
时间窗: Duration of antibiotic course plus 3 weeks
次要结局
- Duration of diarrhea(Duration of antibiotic course plus 3 weeks)
- Quality of life.(Duration of antibiotic course plus 3 weeks)
- Gastrointestinal Symptom Rating Scale score.(Duration of antibiotic course plus 3 weeks)
- Presence of pathogens in fecal samples.(Duration of antibiotic course)
- Incidence of adverse effects.(Duration of antibiotic course plus 3 weeks)