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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

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.

Condition or disease Intervention/treatment Phase
Diarrhea Antibiotic Associated Diarrhea Drug: Lactobacillus reuteri DSM 17938 Drug: Placebo Phase 4

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Lactobacillus Reuteri DSM 17938 in the Prevention of Antibiotic-associated Diarrhea in Children: Protocol of a Randomized Controlled Trial
Study Start Date : December 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Diarrhea

Arm Intervention/treatment
Experimental: L reuteri DSM 17938
L reuteri DSM 17938 2 x 10^8 twice daily
Drug: Lactobacillus reuteri DSM 17938
Lactobacillus reuteri DSM 17938 twice daily 2 x 10^8

Placebo Comparator: Controls
Identically appearing placebo twice daily
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. the need for discontinuation of the antibiotic treatment [ Time Frame: during antibiotic treatment, an average of 10 days ]
  3. 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 ]
  4. 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 ]
  5. adverse events [ Time Frame: during antibiotic treatment, an average of 10 days and 7 days of follow up ]


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02871908


Locations
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Poland
Department of Paediatrics, The Medical University of Warsaw, Poland
Warsaw, Poland, 02-091
Sponsors and Collaborators
Medical University of Warsaw

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hanna Szajewska, Professor and Chair of Pediatrics at the Medical University of Warsaw, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT02871908     History of Changes
Other Study ID Numbers: 12/08/2016
First Posted: August 18, 2016    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Anti-Infective Agents