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

NCT02871908 | Completed Phase 4

• 1 other identifier: 12/08/2016
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea; Antibiotic Associated Diarrhea

Outcome Measures

Primary Outcomes (1)

• frequencies of diarrhea and antibiotic associated diarrhea

  Three different definitions of diarrhea will be used, as the definitions of diarrhea/AAD in published studies vary. These will include diarrhea defined as: (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, and (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). In all cases, loose or watery stools will correspond to scores of 5 to 7 on the BSF scale or A-consistency on the AISS.

  during antibiotic treatment, an average of 10 days and 7 days of follow up

Secondary Outcomes (5)

• infectious diarrhea

  during antibiotic treatment, an average of 10 days and 7 days of follow up

• the need for discontinuation of the antibiotic treatment

  during antibiotic treatment, an average of 10 days

• the need for hospitalization to manage the diarrhea (in outpatients)

  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

  during antibiotic treatment, an average of 10 days and 7 days of follow up

• adverse events

  during antibiotic treatment, an average of 10 days and 7 days of follow up

Study Arms (2)

L reuteri DSM 17938

EXPERIMENTAL

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

Drug: Lactobacillus reuteri DSM 17938

Controls

PLACEBO COMPARATOR

Identically appearing placebo twice daily

Drug: Placebo

Interventions

Lactobacillus reuteri DSM 17938 DRUG

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

L reuteri DSM 17938

Placebo DRUG

Placebo

Controls

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Paediatrics, The Medical University of Warsaw, Poland

Warsaw, 02-091, Poland

Location

Related Publications (1)

• 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.

  PMID: 28057659 DERIVED

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair of Pediatrics at the Medical University of Warsaw

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: August 18, 2016
• Study Start: December 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: March 20, 2018

Record last verified: 2018-03

Locations

PL (1)