Lactulose for the Prevention of Nosocomial Infections in Children
Information source: Bnai Zion Medical Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nosocomial Infection
Intervention: lactulose (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Bnai Zion Medical Center Official(s) and/or principal investigator(s):
Ron Shaoul, Principal Investigator, Affiliation: Bnai Zion Medical Center
Summary
The purpose of this study is to assess the ability of lactulose, a prebiotic agent, to
prevent hospital acquired infection in children
Clinical Details
Official title: Lactulose for the Prevention of Nosocomial Infections in Children
Study design: Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Primary outcome: The incidence of diarrhea
Secondary outcome: Incidence of rotavirus diarrhea
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
Minimum age: 2 Months.
Maximum age: 36 Months.
Gender(s): Both.
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.
Locations and Contacts
Pediatric Department, Bnai Zion Medical Center, Haifa 31048, Israel
Additional Information
Related publications: Mastretta E, Longo P, Laccisaglia A, Balbo L, Russo R, Mazzaccara A, Gianino P. Effect of Lactobacillus GG and breast-feeding in the prevention of rotavirus nosocomial infection. J Pediatr Gastroenterol Nutr. 2002 Oct;35(4):527-31. Szajewska H, Kotowska M, Mrukowicz JZ, Armanska M, Mikolajczyk W. Efficacy of Lactobacillus GG in prevention of nosocomial diarrhea in infants. J Pediatr. 2001 Mar;138(3):361-5. Schumann C. Medical, nutritional and technological properties of lactulose. An update. Eur J Nutr. 2002 Nov;41 Suppl 1:I17-25. Review.
Starting date: January 2006
Ending date: January 2007
Last updated: February 5, 2008
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