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Trial registered on ANZCTR


Registration number
ACTRN12614000533695
Ethics application status
Approved
Date submitted
13/05/2014
Date registered
20/05/2014
Date last updated
20/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of infant formula enriched with butyrate on immune and intestinal functions
Scientific title
administration of a formula enriched with butyrate in healthy newborns to assess an improvement in intestinal and immune functions
Secondary ID [1] 284599 0
none
Universal Trial Number (UTN)
U1111-1156-8042
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prevention of immunological impairment in healty newborns 291898 0
Condition category
Condition code
Diet and Nutrition 292242 292242 0 0
Other diet and nutrition disorders
Inflammatory and Immune System 292243 292243 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 289370 0
Treatment: Other
Intervention code [2] 289392 0
Prevention
Comparator / control treatment
administration of a standard formula not enriched with probiotics and prebiotics
Control group
Active

Outcomes
Primary outcome [1] 292111 0
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
Timepoint [1] 292111 0
at the third and fifth day of life and at the twenty-eighth day of life
Primary outcome [2] 292112 0
Development of functional maturation of intestine through the monitoring of the citrulline levels in blood samples.
Timepoint [2] 292112 0
at twenty-eight days of life
Secondary outcome [1] 308218 0
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.
Timepoint [1] 308218 0
at the third and fifth day of life and at the twenty-eighth day of life

Eligibility
Key inclusion criteria
Caucasian newborns exclusively fed artificially for maternal choice, gestational age greater than 37 weeks . Obtaining informed consent.
Minimum age
0 Days
Maximum age
0 Days
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomization list, Random allocation Software, version 1.0, 2004
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
variables are analyzed by chi squared test. The Spearman correlation test is used to demonstrate the correlation between two continuous variable. Continuous variables are analyzed and expressed as means and standard deviations by ANOVA test. The software for statistical analysis and graphical representation of the results is SPSS for Windows, ver 14, StatsDirect, SamplePower, GraphPad. the number of participants needed to achieve study objectives was determined considering we wish to obtain a difference of at least 15% in the concentrations of antimicrobial peptides between the two groups under consideration (power 87%, p <0.05 alpha error 0.05) and considering a drop out of 20%

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6050 0
Italy
State/province [1] 6050 0

Funding & Sponsors
Funding source category [1] 289229 0
University
Name [1] 289229 0
"Federico II" University of Naples
Address [1] 289229 0
via s. pansini, 5
80131 Naples
Country [1] 289229 0
Italy
Primary sponsor type
University
Name
"Federico II" University of Naples
Address
via s. pansini, 5
80131 Naples
Country
Italy
Secondary sponsor category [1] 287902 0
None
Name [1] 287902 0
Address [1] 287902 0
Country [1] 287902 0

Ethics approval
Ethics application status
Approved

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48378 0
Dr Annalisa Passariello
Address 48378 0
"Federico II" University of Naples
Via S. Pansini, 5
80131 Naples
Country 48378 0
Italy
Phone 48378 0
+39 081 7462680
Fax 48378 0
+39 081 5451278
Email 48378 0
annalisa.passariello@unina.it
Contact person for public queries
Name 48379 0
Dr Annalisa Passariello
Address 48379 0
"Federico II" University of Naples
Via S. Pansini, 5
80131 Naples
Country 48379 0
Italy
Phone 48379 0
+39 081 7462680
Fax 48379 0
+39 081 5451278
Email 48379 0
annalisa.passariello@unina.it
Contact person for scientific queries
Name 48380 0
Dr Annalisa Passariello
Address 48380 0
"Federico II" University of Naples
Via S. Pansini, 5
80131 Naples
Country 48380 0
Italy
Phone 48380 0
+39 081 7462680
Fax 48380 0
+39 081 5451278
Email 48380 0
annalisa.passariello@unina.it

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary