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

NCT ID: NCT02871908

Last Updated: 2018-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-03-31

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).

Conditions

Diarrhea; Antibiotic Associated Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

L reuteri DSM 17938

L reuteri DSM 17938 2 x 10\^8 twice daily

Group Type: EXPERIMENTAL

Lactobacillus reuteri DSM 17938

Intervention Type: DRUG

Lactobacillus reuteri DSM 17938 twice daily 2 x 10\^8

Controls

Identically appearing placebo twice daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Lactobacillus reuteri DSM 17938

Lactobacillus reuteri DSM 17938 twice daily 2 x 10\^8

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

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.

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Hanna Szajewska

Professor and Chair of Pediatrics at the Medical University of Warsaw

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Paediatrics, The Medical University of Warsaw, Poland

Warsaw, , Poland

Countries

Poland

References

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.

Reference Type: DERIVED

PMID: 28057659 (View on PubMed)

Other Identifiers

12/08/2016

Identifier Type: -

Identifier Source: org_study_id