Probiotics for the Prevention of Antibiotic-Associated Diarrhea
关键词
抽象
描述
A two-centred randomized, multi-blind (i.e. patients, caregivers, data collectors, outcome assessors, data managers and analysts), placebo-controlled clinical trial intended to evaluate the efficacy and safety of Bio-K+ (Lactobacillus acidophilus CL1285, Lactobacillus casei LBC80R and Lactobacillus rhamnosus CLR2) in the prevention of AAD in hospitalized children 1 year to 17 years of age administered IV antibiotics.
日期
最后验证: | 03/31/2018 |
首次提交: | 04/11/2016 |
提交的预估入学人数: | 06/24/2016 |
首次发布: | 06/28/2016 |
上次提交的更新: | 04/15/2018 |
最近更新发布: | 04/17/2018 |
实际学习开始日期: | 10/31/2016 |
预计主要完成日期: | 09/30/2017 |
预计完成日期: | 12/31/2017 |
状况或疾病
干预/治疗
Dietary Supplement: Probiotic (BioK+)
Other: Placebo
相
手臂组
臂 | 干预/治疗 |
---|---|
Experimental: Probiotic (BioK+) Children will receive 10-40 billion CFUs/day of Bio-K+ (Lactobacillus acidophilus CL1285, Lactobacillus casei LBC80R and Lactobacillus rhamnosus CLR2), with dose based on their weight. The product will be administered as a strawberry flavored tub of milk. | Dietary Supplement: Probiotic (BioK+) Probiotic (BioK+) with 3 stains of Lactobacillus |
Placebo Comparator: Placebo Strawberry flavored tub of milk, identical (taste, color, odor) to the active Bio-K+ treatment. | Other: Placebo Strawberry flavored tub of milk, identical (taste, color, odor) to the active Bio-K+ treatment. |
资格标准
有资格学习的年龄 | 1 Year 至 1 Year |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: 1. Participants will be children aged 1 year to 17 years admitted to the General Pediatric inpatient unit at The Hospital for Sick Children (Site 1) or McMaster Children's Hospital (Site 2). 2. Participants will be prescribed IV antibiotics with a planned duration of 1 or more days, and a total course of both IV and oral antibiotics, if applicable, of no more than 28 days. 3. Parent (if parent-report) or patient (if patient-report) is able to communicate in English (read, write, speak). Exclusion Criteria: 1. Parental or patient (e.g. child > 12 years old) report of current diarrhea, diarrhea within the last week. 2. Lactose intolerance. 3. Allergies to strawberry, dried citrus pulp, or any other components of the study product. 4. Immuno-compromised patients or those on immunosuppressive agents (e.g. heart or kidney transplant, complex care, sickle cell disease, chemotherapy agents, oral prednisone). 5. Patients with known or potentially compromised gut integrity (e.g. short gut, Inflammatory Bowel Disease, Celiac disease, Irritable Bowel Syndrome, nasogastric, nasojejunal or gastrostomy tube). 6. Children with serious and/or unstable medical conditions (e.g. diabetes, cardiovascular, renal, lung, psychiatric illness, bleeding disorders, etc.). 7. Children admitted to a medical or surgical subspecialty unit. 8. Patients enrolled in another study. 9. Patients previously randomized to this study. 10. Patient is pregnant. |
结果
主要结果指标
1. Incidence of antibiotic-associated diarrhea (AAD) [2 weeks after antibiotic + probiotic completion]
2. Incidence of antibiotic-associated diarrhea (AAD), global impression [2 weeks after antibiotic + probiotic completion]
次要成果指标
1. Severity of AAD [2 weeks after antibiotic completion]
2. Adverse events [2 weeks after antibiotic completion]
3. Duration of AAD [2 weeks after antibiotic completion]