Ignite Creation Date:
2024-05-06 @ 1:13 AM
Last Modification Date:
2024-10-26 @ 11:00 AM
Study NCT ID:
NCT01756040
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2012-12-19
Brief Title:
Intestinal Permeability in Preterm Infants
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Gut Permeability in Very Low Birth Weight Infants
Status:
COMPLETED
Status Verified Date:
2023-11
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:
IPPI
Brief Summary:
Necrotizing enterocolitis NEC is a life-threatening gastrointestinal emergency characterized by increased intestinal permeability affects approximately 7 to 10 of infants 1500 g birthweight and typically occurs within 7 to 14 days of birth Mortality is as high as 30-50 Prematurity is the greatest risk factor for the development of NEC due to the physiological immaturity of the gastrointestinal tract and altered or abnormal gut microbiota Several studies have demonstrated that the initiation of an intense systemic and local inflammatory cascade leads to intestinal necrosis The human intestine is lined by a single layer of cells exquisitely responsive to multiple stimuli and is populated by a complex climax community of microbial partners Under normal circumstances these intestinal cells form a tight but selective barrier to friends and foes microbes and most environmental substances are held at bay but nutrients are absorbed efficiently Epithelial barrier integrity is itself dynamic and matures over time starting soon after birth though the mechanisms regulating dynamic permeability are poorly understood Low birth weight prematurity and early postnatal age are associated with a leaky gut Although intestinal permeability is higher at birth in preterm than term infants there is usually rapid maturation of the intestinal barrier over the first few days of life in both populations The investigators hypothesize that increased levels of measures of intestinal permeability urine lactuloserhamnose LARh and fecal alpha1- antitrypsin will identify infants at high risk for NEC and that intestinal probiotic strains will be associated with intestinal barrier maturation The purpose of the study is to determine whether clinical factors in combination with non-invasive stool test such as antitrypsin A1AT and microbiota composition profile are associated with intestinal permeability determined by excretion of non-metabolized sugar probes in urine LARh ratio These studies may lead to a non-invasive screening test to identify preterm infants at risk for NEC
Detailed Description:
The proposed study will evaluate the intestinal permeability measured by the urinary LaRh ratio at one timepoint between d7-10 of life in 200 preterm infants 24-32 weeks gestation in preparation for a future study of probiotics to improve intestinal permeability in this population
Primary Objective To estimate mean and variance in IP measured by urinary LactuloseRhamnose ratio at 7-10d of life in neonates born between 24 and 32 weeks of gestational age
Secondary Objectives
1 To assess stool microbiome characteristics in association with intestinal permeability in preterm infants measured by the urinary lactuloserhamnose ratio
Primary Objective To estimate mean and variance in IP measured by urinary LactuloseRhamnose ratio at 7-10d of life in neonates born between 24 and 32 weeks of gestational age
Secondary Objectives
1 To assess stool microbiome characteristics in association with intestinal permeability in preterm infants measured by the urinary lactuloserhamnose ratio
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