Effects of infant formula enriched with butyrate on immune and intestinal functions

Not Applicable

Completed

• Conditions: prevention of immunological impairment in healty newborns; Diet and Nutrition - Other diet and nutrition disorders; Inflammatory and Immune System - Normal development and function of the immune system

• Registration Number: ACTRN12614000533695
• Lead Sponsor: Federico II University of Naples

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Caucasian newborns exclusively fed artificially for maternal choice, gestational age greater than 37 weeks . Obtaining informed consent.

Exclusion Criteria

Maternal factors: a history of autoimmune diseases, cancers, infectious or inflammatory diseases that required antibiotic therapy in pregnancy, diabetes, preeclampsia, lipid disorders, vaginal swab positive for Group B streptococcus, prolonged rupture of membranes.
Neonatal Factors: twins, a history of severe asphyxia, meconium aspiration syndrome, immunodeficiencies, congenital infections, genetic disorders and chromosomal abnormalities, malformations.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of innate immunity by measurement of beta-defensins, cathelecidin LL-37 in faecal and blood samples and development of adaptive immunity through the measurement of sIgA in faecal and blood samples[at the third and fifth day of life and at the twenty-eighth day of life];Development of functional maturation of intestine through the monitoring of the citrulline levels in blood samples.[at twenty-eight days of life]

Secondary Outcome Measures

Name	Time	Method
assessment of clinical improvement through evacuative patter, episodes of colic and crying, regurgitation, vomiting. These outcomes is assessed by daily diary completed by infant's mother.[at the third and fifth day of life and at the twenty-eighth day of life]