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NCT01756040 · ClinicalTrials.gov registry record · Phase 1
Intestinal Permeability in Preterm Infants
A Phase 1 study, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- Phase 1
- Development phase
- 211
- Enrollment target
NCT01756040: Completed Phase 1 study, sponsored by University of Maryland, Baltimore.
NCT01756040 is a Phase 1 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 211 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (252% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01756040, a Phase 1 study, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 211 participants
- Enrollment target
Study 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 lactulose/rhamnose (LA/Rh), 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 (
Primary Outcome
Intestinal Permeability measured by urinary excretion of orally administered lactulose/rhamnose (La/Rh ratio)
Interventions
- DRUG Lactulose -rhamnose solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 211 participants |
| Start Date | 2013-02-01 |
| Est. Completion | 2021-08-31 |
| Phase | Phase 1 |
What the finished NCT01756040 record still lists
NCT01756040 is an interventional study that assigns participants to a tested intervention. The registered 211 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (252% higher).
The record links to 0 conditions, and to 1 intervention - of which Lactulose -rhamnose solution is the first listed.
NCT01756040 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01756040 about?
NCT01756040 is a clinical study titled "Intestinal Permeability in Preterm 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 ...
What is the current status of trial NCT01756040?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 211 participants. The study started on 2013-02-01. Estimated completion is 2021-08-31.
What interventions are being tested in trial NCT01756040?
The interventions under investigation include: Lactulose -rhamnose solution (DRUG).
Who is sponsoring clinical trial NCT01756040?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01756040's enrollment target sits among peer trials
211 245th of 2000 higher than 1,756 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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