Probiotics for the Prevention of Antibiotic-Associated Diarrhea (PAID)

The Hospital for Sick Children

Status: Terminated

Conditions: Acute Diarrhea

Treatments: Dietary Supplement: Probiotic (BioK+); Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02817165

1000052303

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups, including a placebo group

Probiotic (BioK+)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Probiotic (BioK+)

Placebo

Placebo Comparator group

Description:

Strawberry flavored tub of milk, identical (taste, color, odor) to the active Bio-K+ treatment.

Treatment:

Other: Placebo