Status:
COMPLETED
The Effects of Lactobacillus Reuteri DSM 17938 on Immunomodulation and Gastric Motility in Preterm Newborns
Lead Sponsor:
University of Bari
Conditions:
Preterm Birth
Eligibility:
All Genders
3-1 years
Phase:
EARLY_PHASE1
Brief Summary
The investigators propose a Phase II interventional trial to investigate the role of Lactobacillus reuteri DSM 17938 on the intestinal motility and immune response of premature infants and further eva...
Detailed Description
Hypothesis Administration of Lactobacillus reuteri to premature infants will improve their intestinal motility when compared with infants receiving placebo. Primary Objective Evaluate the effects of L...
Eligibility Criteria
Inclusion
- Gestational age 30 - 32 weeks. Gestational age will be defined by the best estimate based on prenatal ultrasound in the first trimester, DLM and/or Balard Score after birth.
Exclusion
- Cardiovascular or (respiratory) instability after 48 hours of age - Chromosomal anomalies.
- Major congenital anomalies (complex cardiac anomalies, congenital hydrocephalus, renal dysplasia)
- Congenital (e.g. jejunal atresia) and acquired (e.g. GI perforation) gastrointestinal pathology precluding oral feed and/or requiring major surgical or medical intervention
- Parental refusal
- Prior enrollment into a conflicting clinical trial. Conflicting clinical trial will be those in which the intervention could modify the outcome of the present study, for example studies that could alter the intestinal motility or the immune response of the premature infants.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2011
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00985816
Start Date
October 1 2009
End Date
October 1 2011
Last Update
November 8 2011
Active Locations (1)
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1
Flavia Indrio
Bari, Italy