Clinical trial NCT02871908: Lactobacillus Reuteri DSM 17938 in the Prevention of Antibiotic-associated Diarrhea in Children: Protocol of a Randomized Controlled Trial
Official title: Lactobacillus Reuteri DSM 17938 in the Prevention of Antibiotic-associated Diarrhea in Children: Protocol of a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diarrhea
Antibiotic Associated Diarrhea
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2016-08-18
Enrollment: 250
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to assess the effect of Lactobacillus reuteri DSM 17938 administration for the prevention of diarrhea and AAD in children.

Detailed description: Introduction:

Addition of some probiotics appears to reduce the risk of antibiotic-associated diarrhea (AAD). Effects of probiotics are strain specific, thus the efficacy and safety of each probiotic strain should be established separately. We aim to assess the effect of Lactobacillus reuteri DSM 17938 administration for the prevention of diarrhea and AAD in children.

Methods and analysis:

A total of 250 children younger than 18 years treated with antibiotics will be enrolled into a double-blind, randomized placebo-controlled trial in which they will additionally receive L reuteri DSM 17938 at a dose 2 x 10\^8 colony-forming units or an identically appearing placebo, orally, twice daily, for the entire duration of antibiotic treatment. The primary outcome measures will be the frequency of diarrhea and AAD. Diarrhea will be defined according to one of 3 definitions: (a) ≥3 loose or watery stools per day for a minimum of 48 hours during antibiotic treatment; (b) ≥3 loose or watery stools per day for a minimum of 24 hours during antibiotic treatment; (c) ≥2 loose or watery stools per day for a minimum of 24 hours during antibiotic treatment. AAD will be diagnosed in cases of diarrhea, defined clinically as above, caused by C. difficile or for otherwise unexplained diarrhea (i.e. negative laboratory stool tests for infectious agents).

Eligibility criteria: Inclusion Criteria:

* age younger than 18 years;
* oral or intravenous antibiotic therapy which started within 24 hours of enrollment;
* signed informed consent.

Exclusion Criteria:

* pre-existing acute or chronic diarrhea,
* history of chronic gastrointestinal disease (e.g., inflammatory bowel disease, cystic fibrosis, celiac disease, food allergy) or other severe chronic disease (e.g., neoplastic diseases), immunodeficiency,
* use of probiotics within 2 weeks prior to enrollment,
* use of antibiotics within 4 weeks prior to enrollment,
* prematurity, and exclusive breastfeeding.

Primary outcomes:
measure: frequencies of diarrhea and antibiotic associated diarrhea
timeFrame: during antibiotic treatment, an average of 10 days and 7 days of follow up
Secondary outcomes:
measure: infectious diarrhea
timeFrame: during antibiotic treatment, an average of 10 days and 7 days of follow up
measure: the need for discontinuation of the antibiotic treatment
timeFrame: during antibiotic treatment, an average of 10 days
measure: the need for hospitalization to manage the diarrhea (in outpatients)
timeFrame: during antibiotic treatment, an average of 10 days and 7 days of follow up
measure: the need for intravenous rehydration in any of the study groups
timeFrame: during antibiotic treatment, an average of 10 days and 7 days of follow up
measure: adverse events
timeFrame: during antibiotic treatment, an average of 10 days and 7 days of follow up
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Paediatrics, The Medical University of Warsaw, Poland
Study officials:
References:
citation: Kolodziej M, Szajewska H. Lactobacillus reuteri DSM 17938 in the prevention of antibiotic-associated diarrhoea in children: protocol of a randomised controlled trial. BMJ Open. 2017 Jan 5;7(1):e013928. doi: 10.1136/bmjopen-2016-013928.