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

administration of a formula enriched with butyrate in healthy newborns to assess an improvement in intestinal and immune functions

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000533695

Enrollment

Registered

2014-05-20

Start date

2012-06-04

Completion date

2012-12-03

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of the study is to evaluate the efficacy of a new infant formula containing butyrate, in stimulating the development of neonatal immune system and in improving intestinal immune responses.

Interventions

administation of a standard infant formula enriched with butyrate (30ml/L) given in sachets of 10 mg, administered three times a day for the first 28 days of life. In the first days of life we directly monitor the adherence to the intervention. Then we contact mothers

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Yes

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.

Outcome results