Immunity Modification of Full Term Infants According to the Type of Feeding and Mode of Delivery (NCT03637894) | Clinical Trial Compass
CompletedNot Applicable
Immunity Modification of Full Term Infants According to the Type of Feeding and Mode of Delivery
Italy96 participantsStarted 2015-08-26
Plain-language summary
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.
Who can participate
Age range
1 Day – 7 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline Innate immunity at 30 days of life and at 90 days of life.
Timeframe: 0-7 days of life, at 30 days of life and at 90 days of life.
Trial details
NCT IDNCT03637894
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico