Status:
COMPLETED
Tolerability and Modulatory Action of the Butyrate Releaser N-(1-carbamoyl-2-phenyl-ethyl) Butyramide
Lead Sponsor:
Federico II University
Conditions:
Safety Issues
Eligibility:
All Genders
Up to 3 years
Phase:
NA
Brief Summary
Accumulating evidence is showing that gut microbiota could play a key role in gastrointestinal tract and immune system development and function. Many beneficial effects elicited by gut microbiota are ...
Eligibility Criteria
Inclusion
- otherwise healthy formula fed-neonates
- born at term (\>37 gestational age)
- adequate weight for gestational age
Exclusion
- twins,
- infants with history of severe asphyxia,
- meconium aspiration syndrome,
- immunodeficiency,
- congenital infections,
- genetic diseases and chromosomal abnormalities,
- malformations,
- insufficient reliability or presence of conditions that made the patient's compliance with the protocol unlikely,
- infants with any other condition which, in the opinion of the Investigator, is likely to interfere with the ability of the infant to ingest food, or the normal growth and development of the infant, or the evaluation of the infant.
- In addition, as maternal exclusion factors:
- history of immune diseases,
- tumors,
- infectious or inflammatory diseases that required antibiotic therapy during pregnancy,
- diabetes,
- gestosis,
- dyslipidemia,
- positive vaginal swab for Group B Streptococcus,
- prolonged rupture of membranes.
Key Trial Info
Start Date :
January 9 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04491266
Start Date
January 9 2012
End Date
December 31 2013
Last Update
August 12 2020
Active Locations (1)
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1
University of Naples Federico II
Naples, Italy, 80131