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Intestinal Permeability in Preterm Infants (IPPI)

This study is not yet open for participant recruitment.
Verified January 2013 by University of Maryland
Sponsor:
Collaborator:
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by (Responsible Party):
Rose Viscardi, MD, University of Maryland
ClinicalTrials.gov Identifier:
NCT01756040
First received: December 19, 2012
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Prematurity
Intestinal Permeability
 Drug: Lactulose -rhamnose solution
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Gut Permeability in Very Low Birth Weight Infants

Resource links provided by NLM:

Drug Information available for: Lactulose
U.S. FDA Resources

Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • intestinal permeability [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 50
Study Start Date: February 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Lactulose - rhamnose solution
Preterm Infants age 24-32 weeks gestation
 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

  Eligibility

Ages Eligible for Study:   up to 4 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756040

Contacts
Contact: Rose M Viscardi, MD 410-706-1913

Locations
United States, Maryland
University of Maryland Medical Center Not yet recruiting
Baltimore, Maryland, United States, 21201
Principal Investigator: Rose M Viscardi, MD            
Sponsors and Collaborators
University of Maryland
National Center for Complementary and Alternative Medicine (NCCAM)
Investigators
Principal Investigator: Alessio Fasano, MD Massachusetts General Hospital
Principal Investigator: Rose M Viscardi, MD University of Maryland
  More Information

Publications:

Responsible Party: Rose Viscardi, MD, University of Maryland
ClinicalTrials.gov Identifier: NCT01756040     History of Changes
Other Study ID Numbers: HP-00049647, R34AT006945-01
Study First Received: December 19, 2012
Last Updated: January 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Maryland:
intestinal permeability
preterm infants
dual sugar test

Additional relevant MeSH terms:
Lactulose
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013