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Completed

NCT Number: NCT01968408

Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children

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).

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Key information

Conditions

Diarrhea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

1 month–48 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Pediatrics, Medical University of Warsaw

Warsaw, 01-410, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Lactobacillus reuteri DSM 17938

Dietary Supplement

10(9) CFU/daily

Placebo

Dietary Supplement

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

Effectiveness of Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children: a Randomized, Double-blind Placebo Controlled Trial

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 24, 2013
Registry last updated
Jun 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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