Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00273949
Status:
UNKNOWN
Last Update Posted:
2008-02-06
First Post:
2006-01-09
Brief Title:
Lactulose for the Prevention of Nosocomial Infections in Children
Sponsor:
Bnai Zion Medical Center
Organization:
Bnai Zion Medical Center
Study Overview
Official Title:
Lactulose for the Prevention of Nosocomial Infections in Children
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the ability of lactulose a prebiotic agent to prevent hospital acquired infection in children
Detailed Description:
Despite the adoption of norms regarding enteric isolation nosocomial infectious diarrhea is common in children12 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 admissions1 Infants and toddlers are at the highest risk of acquiring nosocomial viral gastroenteritis12
Probiotic bacteria have been shown to be beneficial in the prevention and treatment of gastrointestinal infections as well as reduction of viral shedding34 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 difference1
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 gut5
Lactulose is a semi-synthetic disaccharide made from lactose by a chemical reaction which was first described in 19306
In contrast to other prebiotics lactulose has up to now been mainly used as a medicinal drug for constipation and hepatic encephalopathy6 In 1957 Petuely published the basic work about lactulose as the bifidus factor which was confirmed by MacGillivray et al6They 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 encephalopathyThe 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 effects6
Our hypothesis is that lactulose with its proven prebiotic properties given to children during their hospital stay would be beneficial in reducing nosocomial infections
Probiotic bacteria have been shown to be beneficial in the prevention and treatment of gastrointestinal infections as well as reduction of viral shedding34 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 difference1
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 gut5
Lactulose is a semi-synthetic disaccharide made from lactose by a chemical reaction which was first described in 19306
In contrast to other prebiotics lactulose has up to now been mainly used as a medicinal drug for constipation and hepatic encephalopathy6 In 1957 Petuely published the basic work about lactulose as the bifidus factor which was confirmed by MacGillivray et al6They 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 encephalopathyThe 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 effects6
Our hypothesis is that lactulose with its proven prebiotic properties given to children during their hospital stay would be beneficial in reducing nosocomial infections
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None