Probiotics for Prevention of Antibiotic-associated Diarrhea
关键词
抽象
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.
日期
| 最后验证: | 12/31/2009 |
| 首次提交: | 03/17/2008 |
| 提交的预估入学人数: | 03/20/2008 |
| 首次发布: | 03/23/2008 |
| 上次提交的更新: | 01/13/2010 |
| 最近更新发布: | 01/14/2010 |
| 实际学习开始日期: | 02/29/2008 |
| 预计主要完成日期: | 08/31/2009 |
| 预计完成日期: | 08/31/2009 |
状况或疾病
干预/治疗
Other: Jarro-Dophilus EPS probiotics
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: 1 Jarrow-Dophilus EPS | |
| Placebo Comparator: 2 Placebo |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 18-75 years of age - Prescribed oral or IV antibiotics by physicians in Saskatoon Health Region's community medical clinics Exclusion Criteria: - 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. |
结果
主要结果指标
1. Incidence of patients experiencing diarrhea [Duration of antibiotic course plus 3 weeks]
次要成果指标
1. Duration of diarrhea [Duration of antibiotic course plus 3 weeks]
2. Quality of life. [Duration of antibiotic course plus 3 weeks]
3. Gastrointestinal Symptom Rating Scale score. [Duration of antibiotic course plus 3 weeks]
4. Incidence of adverse effects. [Duration of antibiotic course plus 3 weeks]
5. Presence of pathogens in fecal samples. [Duration of antibiotic course]
