Lactobacillus Reuteri DSM 17938 in the Prevention of Antibiotic-associated Diarrhea in Children: Protocol of a Randomized Controlled Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02871908
• Date of registration: 16/08/2016
• Prospective Registration: Yes
• Primary sponsor: Medical University of Warsaw
• Public title: Lactobacillus Reuteri DSM 17938 in the Prevention of Antibiotic-associated Diarrhea in Children: Protocol of a Randomized Controlled Trial
• Scientific title: Lactobacillus Reuteri DSM 17938 in the Prevention of Antibiotic-associated Diarrhea in Children: Protocol of a Randomized Controlled Trial
• Date of first enrolment: December 2016
• Target sample size: 250
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02871908
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Poland

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diarrhea

Antibiotic Associated Diarrhea

Intervention(s)

Drug: Placebo

Drug: Lactobacillus reuteri DSM 17938

Primary Outcome(s)

frequencies of diarrhea and antibiotic associated diarrhea [Time Frame: during antibiotic treatment, an average of 10 days and 7 days of follow up]

Secondary Outcome(s)

the need for hospitalization to manage the diarrhea (in outpatients) [Time Frame: during antibiotic treatment, an average of 10 days and 7 days of follow up]

infectious diarrhea [Time Frame: during antibiotic treatment, an average of 10 days and 7 days of follow up]

the need for intravenous rehydration in any of the study groups [Time Frame: during antibiotic treatment, an average of 10 days and 7 days of follow up]

adverse events [Time Frame: during antibiotic treatment, an average of 10 days and 7 days of follow up]

the need for discontinuation of the antibiotic treatment [Time Frame: during antibiotic treatment, an average of 10 days]

Secondary ID(s)

12/08/2016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors