Innate Immunity Clinical Trial
Official title:
Immunity Modification of Full Term Infants According to the Type of Feeding and Mode of Delivery
This is a single-center, double-blind, randomized controlled trial, with parallel groups and
reference group.
The aim of the study was to investigate the immunity of infant born from caesarian section
and fed with formula milk containing fermented matrix a double and triple dosage compare the
first part of the trial FERCT15 assuming a dose-effect relationship of the fermented matrix
with immune response.
Status | Not yet recruiting |
Enrollment | 56 |
Est. completion date | February 2021 |
Est. primary completion date | February 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 7 Days |
Eligibility |
Inclusion Criteria: - Full term healthy infants - Gestational age from 37 to 41 weeks - Weight appropriate for gestational age (from 10th to 90th centile according to World Health Organization chart) - Human milk not available or not possible Exclusion Criteria: - Weight small for gestational age (< 10th centile) or large for gestational age (> 90th centile) according to World Health Organization chart - Congenital abnormalities, chromosomal, hearth, gastrointestinal, respiratory, neurological or metabolic disease. - Perinatal infections - Positive familiarity for milk proteins allergies |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Heinz Italia SpA | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
Indrio F, Ladisa G, Mautone A, Montagna O. Effect of a fermented formula on thymus size and stool pH in healthy term infants. Pediatr Res. 2007 Jul;62(1):98-100. — View Citation
Nocerino R, Paparo L, Terrin G, Pezzella V, Amoroso A, Cosenza L, Cecere G, De Marco G, Micillo M, Albano F, Nugnes R, Ferri P, Ciccarelli G, Giaccio G, Spadaro R, Maddalena Y, Berni Canani F, Berni Canani R. Cow's milk and rice fermented with Lactobacill — View Citation
Thibault H, Aubert-Jacquin C, Goulet O. Effects of long-term consumption of a fermented infant formula (with Bifidobacterium breve c50 and Streptococcus thermophilus 065) on acute diarrhea in healthy infants. J Pediatr Gastroenterol Nutr. 2004 Aug;39(2):147-52. — View Citation
Zagato E, Mileti E, Massimiliano L, Fasano F, Budelli A, Penna G, Rescigno M. Lactobacillus paracasei CBA L74 metabolic products and fermented milk for infant formula have anti-inflammatory activity on dendritic cells in vitro and protective effects against colitis and an enteric pathogen in vivo. PLoS One. 2014 Feb 10;9(2):e87615. doi: 10.1371/journal.pone.0087615. eCollection 2014. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline Innate immunity at 30 days of life and at 90 days of life. | Fecal dosage of catelecidines, alfa and beta defensins and sIgA | 0-7 days of life, at 30 days of life and at 90 days of life. | |
Secondary | Gastrointestinal tolerance | Gastrointestinal tolerance is evaluated by the use of a daily diary computed by the parents to record vomiting/gaseous colics/stool frequency. | 0-7 days of life, at 30 days of life and at 90 days of life | |
Secondary | Weight | weight (g) | 0-7 days of life, at 30 days of life and at 90 days of life. | |
Secondary | Body composition | Body composition assessment in term of fat mass and fat free mass by air displacement | Time Frame: 0-7 days of life and at 90 days of life. | |
Secondary | Anthropometry | length and head circumference (cm) | 0-7 days of life, at 30 days of life and at 90 days of life. | |
Secondary | Microbiota | gut microbiota assessment | 0-7 days of life and at 90 days of life. | |
Secondary | Metabolomics | stool metabolomic analysis | 0-7 days of life and at 90 days of life. |
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