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Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children

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ClinicalTrials.gov Identifier: NCT01968408
Recruitment Status : Completed
First Posted : October 24, 2013
Last Update Posted : June 18, 2015
Sponsor:
Information provided by (Responsible Party):
Hanna Szajewska, Medical University of Warsaw

Brief Summary:

AIM: To determine the efficacy of Lactobacillus reuteri DSM 17938 at a dose of 10(9) CFU for the prevention of nosocomial diarrhea.

TRIAL DESIGN: Double-blind, placebo controlled RCT. INTERVENTION: L reuteri DSM 17938 in a daily dose of 10(9) CFU. PRIMARY OUTCOME: Nosocomial diarrhoea (3 or more loose or watery stools in a 24 h that will occur more than 72 h after admission).


Condition or disease Intervention/treatment Phase
Diarrhea Dietary Supplement: Lactobacillus reuteri DSM 17938 Dietary Supplement: Placebo Phase 3

Detailed Description:
Nosocomial diarrhea is a common problem in hospitalized children. Previously, it has been documented that the administration of L reuteri DSM 17938 at a dose of 10(8) colony forming units (CFU) compared with placebo had no effect on the overall incidence of nosocomial diarrhea (Wanke & Szajewska, J Pediatr 2012). Whether higher doses of L reuteri DSM 17938 have such effects needs to be substantiated in further randomized trials.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children: a Randomized, Double-blind Placebo Controlled Trial
Study Start Date : September 2012
Primary Completion Date : February 2015
Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: L. reuteri DSM 17938

Lactobacillus reuteri DSM 17938,10(9)CFU/daily (for the duration of hospitalization)

ARM I: Rotavirus vaccinated patients

ARM II: Non-rotavirus vaccinated patients

Dietary Supplement: Lactobacillus reuteri DSM 17938
10(9) CFU/daily
Placebo Comparator: Placebo

Placebo consists of an identical formulation in all respects except that the live probiotic bacteria were excluded

for the duration of hospitalization

Dietary Supplement: Placebo



Primary Outcome Measures :
  1. Incidence of nosocomial diarrhea (defined as the passage of 3 or more loose or watery stools in a 24-hour period that will occur more than 72 hours after admission) [ Time Frame: Any time starting 72 h after admission ]

Secondary Outcome Measures :
  1. Incidence of diarrhea- passage of 3 or more loose or watery stools in a 24-h period [ Time Frame: from the time of admission to the time of discharge of the hospital-expected average 3-5 days ]
  2. Duration of diarrhea (ie, time till the last loose or watery stool from the onset of diarrhea) [ Time Frame: during hospitalisation (expected average 3-5 days) and 72 h after discharge ]
  3. Need and the length of intravenous rehydration due to diarrhea [ Time Frame: During the hospitalization-expected average 3-5 days ]
  4. Prolongation of the hospitalization due to nosocomial diarrhea [ Time Frame: during the hospitalization-expected average 3-5 days ]
  5. Incidence of rotavirus diarrhea (ie, detection of rotavirus or antigen in the stools) [ Time Frame: 72 hours after admission to the hospital to 72 hours after discharge ]
    Positive test for rotavirus or antigen in the stool sample

  6. Incidence of chronic diarrhea- lasting more than 14 days [ Time Frame: untill 14 days after onset of diarrhea ]
  7. Length of hospital stay [ Time Frame: During hospitalisation-expected average 3-5 days ]
  8. Adverse effects [ Time Frame: During hospitalisation (expected average 3-5 days) plus 72 h after discharge ]


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Ages Eligible for Study:   1 Month to 48 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children aged 1-48 mo admitted to the hospital for reasons other than diarrhea
  • Signed informed consent.

Exclusion Criteria:

  • Acute gastroenteritis within 3 days before admission
  • Symptoms other than diarrhea suggesting gastroenteritis
  • Use of probiotics within 7 days before admission
  • Immunodeficiency disorders
  • Breastfeeding >50%
  • Underlying gastrointestinal tract disorder
  • Malnutrition (weight/high <3pc)

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): NCT01968408


Locations
Poland
Department of Pediatrics, Medical University of Warsaw
Warsaw, Poland, 01-410
Sponsors and Collaborators
Medical University of Warsaw
Investigators
Principal Investigator: Hanna Szajewska, MD, Profesor Medical University of Warsaw

Responsible Party: Hanna Szajewska, Proffesor, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT01968408     History of Changes
Other Study ID Numbers: KB/125/2012
First Posted: October 24, 2013    Key Record Dates
Last Update Posted: June 18, 2015
Last Verified: June 2015

Keywords provided by Hanna Szajewska, Medical University of Warsaw:
nosocomial diarrhea
Lactobacillus reuteri DSM 17938
rotavirus diarrhea
probiotics

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms