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Intestinal Permeability in Preterm Infants (IPPI)

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ClinicalTrials.gov Identifier: NCT01756040
Recruitment Status : Active, not recruiting
First Posted : December 24, 2012
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Rose Viscardi, University of Maryland

December 19, 2012
December 24, 2012
April 17, 2018
February 2013
December 2020   (Final data collection date for primary outcome measure)
intestinal permeability [ Time Frame: 18 months ]
To develop a 'natural history' metabolic and microbiota profile, as well as examine if an 'index' of clinical indicators that monitor increased levels of intestinal permeability [serum zonulin; urine LA/Rh, fecal alpha1-antitrypsin, and possibly toll-like receptor 4 (TLR4, single nucleotide polymorphisms (SNPs) will identify very low birth weight(VLBW)neonates at high risk of NEC
intestinal permeability [ Time Frame: 18 months ]
To develop a 'natural history' metabolic and microbiota profile, as well as examine if an 'index' of clinical indicators that monitor increased levels of intestinal permeability [serum zonulin; urine LA/Rh, fecal alpha1-antitrypsin, and possibly TLR4 SNPs will identify VLBW neonates at high risk of NEC
Complete list of historical versions of study NCT01756040 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Intestinal Permeability in Preterm Infants
Gut Permeability in Very Low Birth Weight Infants
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 (serum zonulin, urine lactulose/rhamnose (LA/Rh), and fecal alpha1- antitrypsin will identify infants at high risk for NEC. The purpose of the study is to determine whether measurement of intestinal permeability in serum will correlate with other markers of intestinal barrier leakiness measured in urine (LA/Rh) and stool (alpha-1 antitrypsin. If there is good correlation, then zonulin or serum rhamnose may be a useful measure to identify preterm babies at risk for NEC.
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Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
  • Prematurity
  • Intestinal Permeability
Drug: Lactulose -rhamnose solution
Measurement of intestinal permeability by use of mon- digestible sugars known not to cross the intestinal barrier in normal healthy intestinal tissue
Other Name: dual sugar solution
Lactulose - rhamnose solution
Preterm Infants age 24-32 weeks gestation
Intervention: Drug: Lactulose -rhamnose solution

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
Same as current
December 2020
December 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • < 4 days
  • Gestational age 24-32 weeks

Exclusion criteria:

  • Nonviable or planned withdrawal of care
  • Significant GI dysfunction (e.g. heme-positive stools, abdominal distension (girth >2 cm baseline), or bilious emesis/aspirates.
  • Triplet or higher order multiple
  • Severe asphyxia
  • Lethal chromosome abnormalities
  • Cyanotic congenital heart disease
  • Intestinal atresia or perforation
  • Abdominal wall defects
  • Known galactosemia or other galactose intolerance
Sexes Eligible for Study: All
up to 4 Days   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01756040
HP-00049647
R34AT006945-01 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Rose Viscardi, University of Maryland
University of Maryland
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Alessio Fasano, MD Massachusetts General Hospital
Principal Investigator: Rose M Viscardi, MD University of Maryland
University of Maryland
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP