Probiotics for the Prevention of Antibiotic-Associated Diarrhea
Maneno muhimu
Kikemikali
Maelezo
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.
Tarehe
Imethibitishwa Mwisho: | 03/31/2018 |
Iliyowasilishwa Kwanza: | 04/11/2016 |
Uandikishaji uliokadiriwa Uliwasilishwa: | 06/24/2016 |
Iliyotumwa Kwanza: | 06/28/2016 |
Sasisho la Mwisho Liliwasilishwa: | 04/15/2018 |
Sasisho la Mwisho Lilichapishwa: | 04/17/2018 |
Tarehe halisi ya kuanza kwa masomo: | 10/31/2016 |
Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 09/30/2017 |
Tarehe ya Kukamilisha Utafiti: | 12/31/2017 |
Hali au ugonjwa
Uingiliaji / matibabu
Dietary Supplement: Probiotic (BioK+)
Other: Placebo
Awamu
Vikundi vya Arm
Mkono | Uingiliaji / matibabu |
---|---|
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. |
Vigezo vya Kustahiki
Zama zinazostahiki Kujifunza | 1 Year Kwa 1 Year |
Jinsia Inastahiki Kujifunza | All |
Hupokea Wajitolea wa Afya | Ndio |
Vigezo | 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. |
Matokeo
Hatua za Matokeo ya Msingi
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]
Hatua za Matokeo ya Sekondari
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]