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

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ClinicalTrials.gov Identifier: NCT02871908
Recruitment Status : Completed
First Posted : August 18, 2016
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Hanna Szajewska, Medical University of Warsaw

Tracking Information
First Submitted Date  ICMJE August 16, 2016
First Posted Date  ICMJE August 18, 2016
Last Update Posted Date March 20, 2018
Study Start Date  ICMJE December 2016
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2016)
frequencies of diarrhea and antibiotic associated diarrhea [ Time Frame: during antibiotic treatment, an average of 10 days and 7 days of follow up ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 17, 2016)
frequencies of diarrhea and antibiotic associated diarrhea [ Time Frame: during antibiotic treatment and 7 days of follow up ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2016)
  • infectious diarrhea [ Time Frame: during antibiotic treatment, an average of 10 days and 7 days of follow up ]
    rotavirus, adenovirus, norovirus, Salmonella, Shigella, Campylobacter, Yersinia and C. difficile
  • the need for discontinuation of the antibiotic treatment [ Time Frame: during antibiotic treatment, an average of 10 days ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2016)
  • infectious diarrhea [ Time Frame: during antibiotic treatment and 7 days of follow up ]
    rotavirus, adenovirus, norovirus, Salmonella, Shigella, Campylobacter, Yersinia and C. difficile
  • the need for discontinuation of the antibiotic treatment [ Time Frame: during antibiotic treatment ]
  • the need for hospitalization to manage the diarrhea (in outpatients) [ Time Frame: during antibiotic treatment and 7 days of follow up ]
  • the need for intravenous rehydration in any of the study groups [ Time Frame: during antibiotic treatment and 7 days of follow up ]
  • adverse events [ Time Frame: during antibiotic treatment and 7 days of follow up ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lactobacillus Reuteri DSM 17938 in the Prevention of Antibiotic-associated Diarrhea in Children: Protocol of a Randomized Controlled Trial
Official Title  ICMJE Lactobacillus Reuteri DSM 17938 in the Prevention of Antibiotic-associated Diarrhea in Children: Protocol of a Randomized Controlled Trial
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Diarrhea
  • Antibiotic Associated Diarrhea
Intervention  ICMJE
  • Drug: Lactobacillus reuteri DSM 17938
    Lactobacillus reuteri DSM 17938 twice daily 2 x 10^8
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: L reuteri DSM 17938
    L reuteri DSM 17938 2 x 10^8 twice daily
    Intervention: Drug: Lactobacillus reuteri DSM 17938
  • Placebo Comparator: Controls
    Identically appearing placebo twice daily
    Intervention: Drug: Placebo
Publications * Kołodziej 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 17, 2016)
250
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2018
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02871908
Other Study ID Numbers  ICMJE 12/08/2016
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hanna Szajewska, Medical University of Warsaw
Study Sponsor  ICMJE Medical University of Warsaw
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical University of Warsaw
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP