Partially Hydrolyzed Whey Protein Formula for Infants With Mild Allergy (NCT07449507) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Partially Hydrolyzed Whey Protein Formula for Infants With Mild Allergy
160 participantsStarted 2026-04-01
Plain-language summary
This study is a prospective, multicenter, randomized controlled trial designed to evaluate the clinical efficacy, tolerance, and safety of a partially hydrolyzed whey protein formula in infants with mild allergic symptoms. Partially hydrolyzed formulas contain low-molecular weight peptides and have been shown to improve protein tolerance and digestibility and to reduce allergenicity compared with intact cow's milk protein formulas. However, evidence regarding their therapeutic effects in infants who have already developed allergic symptoms remains limited.
Eligible infants with mild allergic manifestations who are predominantly formula-fed will be randomly assigned in a 1:1 ratio to receive either a partially hydrolyzed whey protein formula or an intact cow's milk protein formula. Infants in the intervention group will receive a 100% partially hydrolyzed whey protein formula during the initial intervention period and will transition to a 60% partially hydrolyzed whey protein formula after reaching 6 months of age, while infants in the control group will continue feeding with an intact protein formula.
The primary outcome is the overall improvement rate of allergic symptoms after 2 weeks of intervention. Secondary outcomes include tolerance after transition to the follow-on formula at 6 months of age, changes in skin, gastrointestinal, and respiratory symptoms, growth parameters, and safety outcomes. The results of this study are expected to provide evidence to support nutritional management strategies for infants with mild allergic symptoms.
Who can participate
Age range
12 Weeks – 20 Weeks
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
. Infants aged ≥12 weeks and \<20 weeks at the time of screening.
. Gestational age ≥37 weeks.
. Birth weight ≥2500g.
. Presence of mild allergic symptoms (e.g., skin, gastrointestinal, or respiratory symptoms).
. Infants who are predominantly formula-fed or mixed-fed at the time of enrollment.
. Legal guardian has provided written informed consent and agrees to participate in the study.
Exclusion criteria
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.
. Diagnosed with moderate or severe food allergies, including a history of allergic conditions such as atopic dermatitis, wheezing bronchitis, or severe allergic reactions.
. Confirmed cow's milk protein allergy.
. Currently receiving a partially hydrolyzed formula or any other specialized formula.
. Exclusively breastfed infants.
. Known allergy or intolerance to the study formula.
. Presence of severe illness (e.g., digestive, respiratory, neurological infections, other gastrointestinal diseases, gastrointestinal anatomical abnormalities, congenital malformations, or growth retardation).
. Infants with a history of severe diseases such as heart, brain, liver, kidney, hematologic, connective tissue, endocrine diseases, or mental disorders.
. Infants who have undergone major surgery that may impact the study outcomes.