Clinical trial NCT02817165: Probiotics for the Prevention of Antibiotic-Associated Diarrhea
Official title: Probiotics in the Prevention of Antibiotic-Associated Diarrhea in Hospitalized Children: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Diarrhea
Keywords: Probiotics, diarrhea, antibiotic, children, hospital
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: McMaster University
First posted: 2016-06-29
Enrollment: 16
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In North America, one of the most common reasons for hospitalization in previously healthy children is for the treatment of infections with antibiotics. This study will determine if, in previously healthy children hospitalized and prescribed intravenous (IV) antibiotics, the co-administration of a probiotic milk product containing good bacteria, is safe and effective for reducing AAD, as compared to a placebo (identical appearing milk product). This will be a two-center, randomized, masked, placebo-controlled clinical trial. The results of this study will help inform clinicians and families on the use of probiotics in the prevention of AAD, a common side effect of antibiotic use among hospitalized children.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of antibiotic-associated diarrhea (AAD)
timeFrame: 2 weeks after antibiotic + probiotic completion
measure: Incidence of antibiotic-associated diarrhea (AAD), global impression
timeFrame: 2 weeks after antibiotic + probiotic completion
Secondary outcomes:
measure: Severity of AAD
timeFrame: 2 weeks after antibiotic completion
measure: Adverse events
timeFrame: 2 weeks after antibiotic completion
measure: Duration of AAD
timeFrame: 2 weeks after antibiotic completion
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Patricia Parkin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Gordon Guyatt, MD
role: STUDY_CHAIR
References:
citation: Johnston BC, Shamseer L, da Costa BR, Tsuyuki RT, Vohra S. Measurement issues in trials of pediatric acute diarrheal diseases: a systematic review. Pediatrics. 2010 Jul;126(1):e222-31. doi: 10.1542/peds.2009-3667. Epub 2010 Jun 21.
citation: Johnston B, Pirrello D, Lytvyn L, Mahant S, Sherman P, Ship N, Parkin P. Prospective cohort study of antibiotic-associated diarrhea among hospitalized children. Symposium Probio, Quebec City, Canada. (October 29, 2015).
citation: Goldenberg JZ, Lytvyn L, Steurich J, Parkin P, Mahant S, Johnston BC. Probiotics for the prevention of pediatric antibiotic-associated diarrhea. Cochrane Database Syst Rev. 2015 Dec 22;(12):CD004827. doi: 10.1002/14651858.CD004827.pub4.