Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00282113
Status:
COMPLETED
Last Update Posted:
2010-01-28
First Post:
2006-01-23
Brief Title:
Effects of Probiotic and Prebiotic Combinations on Premature Infants
Sponsor:
University of California Davis
Organization:
University of California Davis
Study Overview
Official Title:
Efficacy of a Prebiotic and Probiotic Combination in Preterm Infants
Status:
COMPLETED
Status Verified Date:
2009-12
Last Known Status:
None
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 see how oral preparations containing both probiotics and prebiotics impact the growth bacterial colonization of the intestines and fecal short chain fatty acid content in premature infants Our hypothesis is that short term growth will be improved the stool will have more healthy bacteria and the fecal short chain fatty acid content will increase in the babies who receive the probioticprebiotic combinations compared to control groups
Detailed Description:
Premature infants are at risk for a devastating infection of the intestines due to the immaturity of their intestines and immune system Probiotics are bacteria with healthful qualities that are taken by mouth to improve the number of healthy bacteria in the intestines Probiotics have been shown in several studies outside the US to decrease the risk of serious intestinal infection and in one small study to improve the rate of weight gain in premature infants Prebiotics are food supplements that stimulate the growth of healthy bacteria and suppress the growth of unhealthy bacteria Prebiotics have been shown to improve the numbers of healthy bacteria in the stool of premature babies Our study is designed to compare two over the counter probioticprebiotic combinations to each other and to a control group Infants less than 35 weeks with a birthweight of 750-2000 gm are eligible and must be enrolled in the study within the first week of life The babies are randomly assigned to either a control group no probioticprebiotic just a placebo a group which receives Culturelle Lactobacillus rhamnosus GG plus fructo-oligosaccharide ConAgra or a group which receives ProBioPlus three strains of Bifidobacteria plus Lactobacillus acidophilus plus fructo-oligosaccharide UAS Laboratories The babies receive the study product by mouth twice daily for 28 days or until discharge whichever comes first Weekly measurements weight length head size and stool cultures are performed Clinical progress is closely monitored and any episodes of infection are recorded
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