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Lactulose for the Prevention of Nosocomial Infections in Children
This study is ongoing, but not recruiting participants.
First Received: January 9, 2006   Last Updated: February 5, 2008   History of Changes
Sponsored by: Bnai Zion Medical Center
Information provided by: Bnai Zion Medical Center
ClinicalTrials.gov Identifier: NCT00273949
  Purpose

The purpose of this study is to assess the ability of lactulose, a prebiotic agent, to prevent hospital acquired infection in children


Condition Intervention
Nosocomial Infection
Drug: lactulose

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title: Lactulose for the Prevention of Nosocomial Infections in Children

Resource links provided by NLM:


Further study details as provided by Bnai Zion Medical Center:

Primary Outcome Measures:
  • The incidence of diarrhea

Secondary Outcome Measures:
  • Incidence of rotavirus diarrhea

Estimated Enrollment: 100
Study Start Date: January 2006
Estimated Study Completion Date: January 2007
Detailed Description:

Despite the adoption of norms regarding enteric isolation, nosocomial infectious diarrhea is common in children(1;2). Viral pathogens, especially rotavirus are responsible for most of the cases. Depending on population, type of hospital, and standard of care, the reported incidence rate ranges from 8 to 33 episodes per 100 admissions(1). Infants and toddlers are at the highest risk of acquiring nosocomial viral gastroenteritis(1;2).

Probiotic bacteria have been shown to be beneficial in the prevention and treatment of gastrointestinal infections as well as reduction of viral shedding(3;4). A recent study by Szajewska et al. (2) showed a significant reduction of nosocomial infections from 33% to 7% by prophylactic treatment with LGG during the hospital stay. Another study however, did not show any difference(1).

Another approach is to use prebiotic treatment. Prebiotics are defined as non-digestible substances that, when ingested, selectively promote the growth and establishment of beneficial probiotic-like bacteria normally present in the gut(5).

Lactulose is a semi-synthetic disaccharide made from lactose by a chemical reaction which was first described in 1930(6). In contrast to other prebiotics, lactulose has up to now been mainly used as a medicinal drug for constipation and hepatic encephalopathy(6). In 1957 Petuely published the basic work about lactulose as "the bifidus factor" which was confirmed by MacGillivray et al(6).They found that the composition of the colonic microflora of bottle-fed babies is very much like that of adults while if lactulose is added to the formula milk such babies have the same composition as breast-fed babies.

Lactulose has been used for 40 years in the treatment of constipation [10] and for more than 30 years for encephalopathy.The dosages used in PSE are up to four times higher than those usually applied in constipation. No putative or definite evidence of mutagenic, genotoxic or teratogenic effects of lactulose has been obtained in human use. Animal studies in rats and rabbits also did not reveal any teratogenic or reproduction-toxicologic effects, and even high dosages have had no deleterious effects(6)

Our hypothesis is that lactulose, with its proven prebiotic properties, given to children during their hospital stay, would be beneficial in reducing nosocomial infections.

  Eligibility

Ages Eligible for Study:   2 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All children aged 2 to 36 months who are admitted to the hospital for reasons other than diarrhea will be eligible for the study.

Exclusion Criteria:

  • Children with a history of probiotics or prebiotics use within 7 days before admission, acute gastroenteritis within 3 days before admission, vomiting, treated chronic constipation, known anatomic problem in the gastrointestinal tract will be excluded from the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00273949

Locations
Israel
Pediatric Department, Bnai Zion Medical Center
Haifa, Israel, 31048
Sponsors and Collaborators
Bnai Zion Medical Center
Investigators
Principal Investigator: Ron Shaoul Bnai Zion Medical Center
  More Information

Publications:
Study ID Numbers: BZ00001
Study First Received: January 9, 2006
Last Updated: February 5, 2008
ClinicalTrials.gov Identifier: NCT00273949     History of Changes
Health Authority: Israel: Ministry of Health

Keywords provided by Bnai Zion Medical Center:
Lactulose
Prebiotics
Nosocomial infection
children
infants

Study placed in the following topic categories:
Cross Infection
Lactulose

Additional relevant MeSH terms:
Communicable Diseases
Therapeutic Uses
Gastrointestinal Agents
Infection
Pharmacologic Actions
Cross Infection
Lactulose

ClinicalTrials.gov processed this record on September 01, 2009