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

Diarrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02871908
• Other study ID #: 12/08/2016
• Status: Completed
• Phase: Phase 4
• First received: August 16, 2016
• Last updated: March 18, 2018
• Start date: December 2016
• Est. completion date: March 2018

Study information

• Verified date: March 2018
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Antibiotic Associated Diarrhea
• Diarrhea

Intervention

Drug:
• Lactobacillus reuteri DSM 17938
Lactobacillus reuteri DSM 17938 twice daily 2 x 10^8
• Placebo
Placebo

Locations

Country	Name	City	State
Poland	Department of Paediatrics, The Medical University of Warsaw, Poland	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	infectious diarrhea	rotavirus, adenovirus, norovirus, Salmonella, Shigella, Campylobacter, Yersinia and C. difficile	during antibiotic treatment, an average of 10 days and 7 days of follow up
Secondary	the need for discontinuation of the antibiotic treatment		during antibiotic treatment, an average of 10 days
Secondary	the need for hospitalization to manage the diarrhea (in outpatients)		during antibiotic treatment, an average of 10 days and 7 days of follow up
Secondary	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
Secondary	adverse events		during antibiotic treatment, an average of 10 days and 7 days of follow up