Partially Hydrolyzed Whey Protein Formula for Infants With Mild Allergy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Partially Hydrolyzed Whey Protein Formula, Intact Cow's Milk Protein Formula.
- Who it may be relevant to
- Registry conditions: Mild Allergic Symptoms in Infants, Infant Feeding Intolerance. Basic parameters: 12 Weeks — 20 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter, Randomized Controlled Study of a Partially Hydrolyzed Whey Protein Formula in Infants With Mild Allergy.
Overview
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.
Interventions
- Dietary supplement Partially Hydrolyzed Whey Protein Formula
Infants receive a 100% partially hydrolyzed whey protein formula during the initial intervention period and transition to a 60% partially hydrolyzed whey protein follow-on formula after 6 months of age. - Dietary supplement Intact Cow's Milk Protein Formula
intact cow's milk protein formula during the intervention period with standard feeding guidance.
Primary outcome measures
- Overall Improvement Rate of Allergic Symptoms [Time frame: 2 weeks after the intervention]
Secondary outcome measures (2)
- Safety Assessment [Time frame: Week 2, Week 4, Week 8, and 2 weeks post-formula switch]
- Change from Baseline in Allergy-Related Symptom Scores and Response Category [Time frame: Baseline, Week 4, Week 8]
Eligibility criteria
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
- 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.
- Infants who have used systemic immune-modulating medications (e.g., anti-allergy drugs, corticosteroids, immunosuppressants, biological agents) within the last 2 weeks.
- Infants who have used gastrointestinal medications (e.g., proton pump inhibitors, gastrointestinal motility agents, or digestive remedies) within the last 7 days.
- Infants who have used probiotics within the last 7 days.
- Parents who are unable to report the occurrence of symptoms or adhere to the study visits and protocol requirements.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07449507 · PHASE