Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function (NCT06943469) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function
Belgium, France, Germany400 participantsStarted 2025-04-10
Plain-language summary
The main purpose of this study is to assess the efficacy of a partially hydrolyzed formula with synbiotics in halting one of the first steps of the allergic march (atopic dermatitis) in infants at risk of allergy. Other efficacy and safety parameters will be assessed as well.
Who can participate
Age range
1 Day – 14 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
. Written informed consent has been obtained from at least one parent or legally acceptable representative (LAR), if applicable
. Infant gestational age ≥ 37 completed weeks
. Infant birth weight of ≥ 2.5 kg and ≤ 4.5 kg
. Infant postnatal age ≤ 14 days (date of birth = day 0) at enrollment
. Infant from singleton birth or infant from multiple births may if all birth siblings are enrolled.
. At least one biological parent or sibling has (or had) a medically diagnosed history of allergy, based on response to a simple screening questionnaire
. a. For the breastfed reference group only: infant is exclusively breastfed since birth with no intake of formula, and their parent(s) have the intention to continue exclusive breastfeeding until at least 4 months of age.
. Parents/LAR must be able to provide evidence of parental authority and identity.
Exclusion criteria
. Infectious, metabolic, congenital, genetic, gastrointestinal illness or any other condition (e.g., gastrointestinal surgery) that could impact oral feeding, growth or study outcomes.
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.
. Infants with special dietary needs other than standard infant formula (e.g., extensively hydrolyzed formula, amino acid formula, special formula for metabolic diseases) or requiring tube feeding.
. Infant has already been diagnosed with allergy by a physician, including AD and/or cow's milk allergy.
. Infant is currently participating or has previously participated in another clinical trial prior to enrollment.
. Infant's parents or LARs have not reached legal age of majority (18 years).