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NCT Number: NCT01046656

L Reuteri for the Prevention of Nosocomial Diarrhea

Nosocomial diarrhea is any diarrhea that a patient contracts in a health-care institution. In children, it is commonly caused by enteric pathogens, especially rotavirus. The reported incidence ranges from 4.5 to 22.6 episodes per 100 admissions. Nosocomial diarrhea may prolong the hospital stay and increase medical costs. One of the potential strategies for the prevention of nosocomial infections is the use of probiotics. The number of studies have shown the efficacy of Lactobacillus reuteri (DSM 17938) in the treatment of acute diarrhea. However, there are no data on the efficacy of L. reuteri in the prevention of nosocomial diarrhea. The investigators, therefore, plan to perform the study with the aim of evaluating the role of Lactobacillus reuteri DSM 17938 administration in the prevention of nosocomial gastroenteritis in a pediatric hospital setting.

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Key information

Conditions

Nosocomial Infection Cross Infection Diarrhea Digestive System Diseases Disease Attributes Gastroenteritis Gastrointestinal Diseases Iatrogenic Disease Infections Pathologic Processes 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

The Medical University of Warsaw, Department of Paediatrics

Warsaw, 01-184, Poland

About this study

Infants will be randomly assigned at admission to receive L. reuteri in dose of 10(8) CFU in 5 drops of oil suspension or a comparable placebo once daily for the entire duration of their hospital stay.

Patients will be evaluated daily for stool number and consistency. In case of loose or watery stools occurring within 3 days after discharge, patients will be advised to contact hospital physicians. Stool samples obtained weekly and during an episode of diarrhea, will be analyzed for bacteria with standard stool cultures and rotavirus and adenovirus antigen.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age 1-48 mo
  • cause of hospitalization must be other than acute gastroenteritis or diarrhea

Exclusion criteria

  • acute gastroenteritis within 3 days before admission
  • other symptoms which suggest gastroenteritis
  • usage of probiotics and/or prebiotics within 7 days before admission
  • visible blood in the stool
  • patient in bad condition
  • lack of approval from patients parents
  • breastfeeding
  • no compliance

Treatment and study plan

Lactobacillus reuteri (DSM 17938)

Dietary Supplement

5 drops once daily (10(8) CFU) for the entire duration of hospital stay

Primary outcomes

  1. Nosocomial diarrhea (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: from 72nd hrs till the and of hospitalization no longer than 14 days

Secondary outcomes

  1. Length of hospital stay in days

    Time frame: from 72nd hrs till the and of hospitalization no longer than 14 days

  2. Recurrent diarrhea - recurrence of diarrhea after 48h of normal stools

    Time frame: from 72nd hrs till the and of hospitalization no longer than 14 days

  3. Chronic diarrhea - diarrhea beyond 14 days

    Time frame: from 72nd hrs till the and of hospitalization no longer than 14 days

  4. Diarrhea - the passage of 3 or more loose of watery stools in a 24 h period

    Time frame: from 72nd hrs till the and of hospitalization no longer than 14 days

  5. Rotavirus infection - detection of rotavirus or antigen in the stools

    Time frame: from 72nd hrs till the and of hospitalization no longer than 14 days

  6. Duration of diarrhea - time till the last loose watery stools from the onset of diarrhea measured in days)

    Time frame: from 72nd hrs till the and of hospitalization no longer than 14 days

  7. Need for rehydration

    Time frame: from 72nd hrs till the and of hospitalization no longer than 14 days

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

Efficacy of Lactobacillus Reuteri DSM 17938 in the Prevention of Nosocomial Diarrhea in Children. Randomized Double-blind Placebo Controlled Trial

Acronym: PND

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 12, 2010
Registry last updated
Jan 31, 2012

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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