Nutrition Clinical Trial
Official title:
Immunity Modification of Full Term Infants According to the Type of Feeding and Mode of Delivery
NCT number | NCT03637894 |
Other study ID # | FERT15 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 26, 2015 |
Est. completion date | June 21, 2017 |
Verified date | January 2018 |
Source | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a single-center, double-blind, randomized controlled trial, with parallel groups and reference group. The aim of the study was to investigate whether feed a fermented formula milk leads to an increase of anti-microbial peptides such as catelecidine, alpha and beta defensins and secretory-IgA, compared to feed a standard formula (Plasmon Primigiorni), according to mode of delivery. Breastfed infants were the reference group.
Status | Completed |
Enrollment | 96 |
Est. completion date | June 21, 2017 |
Est. primary completion date | June 21, 2017 |
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 |
---|---|---|---|
Italy | Fondazione Ca' Granda Ospedale Maggiore Policlinico | Milan |
Lead Sponsor | Collaborator |
---|---|
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Heinz Italia SpA |
Italy,
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):1 — 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 again — 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 was 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 | 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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