This trial is active, not recruiting.

Condition nosocomial infection
Treatment lactulose
Sponsor Bnai Zion Medical Center
Start date January 2006
End date January 2007
Trial size 100 participants
Trial identifier NCT00273949, BZ00001


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking double-blind
Primary purpose prevention

Primary Outcomes

The incidence of diarrhea
time frame:

Secondary Outcomes

Incidence of rotavirus diarrhea
time frame:

Eligibility Criteria

Male or female participants from 2 months up to 36 months old.

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.

Additional Information

Official title Lactulose for the Prevention of Nosocomial Infections in Children
Principal investigator Ron Shaoul
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2008.
Information provided to ClinicalTrials.gov by Bnai Zion Medical Center.