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NCT Number: NCT07449507

Partially Hydrolyzed Whey Protein Formula for Infants With Mild Allergy

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.

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Key information

Conditions

Mild Allergic Symptoms in Infants Hypersensitivity Immune System Diseases Infant Feeding Intolerance

Age range

12 week–20 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Partially Hydrolyzed Whey Protein Formula

Dietary Supplement

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.

Intact Cow's Milk Protein Formula

Dietary Supplement

intact cow's milk protein formula during the intervention period with standard feeding guidance.

Primary outcomes

  1. Overall Improvement Rate of Allergic Symptoms

    Time frame: 2 weeks after the intervention

    The overall response rate is defined as the proportion of participants achieving either marked response or partial response based on the Therapeutic Index (n) calculated from the Total Symptom Index (TSI) at Week 2 (Day 14 ± 2 days) compared to Baseline (Day 0). TSI is a composite score integrating both skin and gastrointestinal symptoms, calculated as: TSI = (SCORAD score / 103 × 100) × 0.5 + (I-GSAS daily total score / 21 × 100) × 0.5. The SCORAD (SCORing Atopic Dermatitis) index ranges from 0 to 103, and the I-GSAS (Infant Gastrointestinal Symptoms Assessment Scale) daily total score ranges from 0 to 21. The Therapeutic Index (n) is computed as: n = (Baseline TSI - Week 2 TSI) / Baseline TSI × 100%. Response categories are: marked response (n ≥ 60%), partial response (20% ≤ n < 60%), and no response (n < 20%). The overall response rate is calculated as (number of participants with marked or partial response) / (number of participants in the intention-to-treat [ITT] population) × 10

Secondary outcomes

  1. Safety Assessment

    Time frame: Week 2, Week 4, Week 8, and 2 weeks post-formula switch

    Evaluation of safety outcomes, including the incidence, severity, and type of adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs) in the experimental group compared to the control group.

  2. Change from Baseline in Allergy-Related Symptom Scores and Response Category

    Time frame: Baseline, Week 4, Week 8

    Comparison between the experimental group and the control group regarding the mean change from Baseline in allergy-related composite symptom scores, as well as the distribution of response categories (e.g., marked, partial, no response), at Week 4 and Week 8.

Other outcomes

  1. Incidence of Skin, Gastrointestinal, and Respiratory Symptoms

    Time frame: Week 2, Week 4, Week 8, and 2 weeks post-formula switch

    Proportion of participants in each group presenting with skin symptoms (SCORAD score > 0), gastrointestinal symptoms (I-GSAS score > 0), and respiratory symptoms (respiratory score > 0) at each specified time point.

  2. Proportion of Participants with Symptom Relapse After Switching to Stage 2 Formula

    Time frame: 2 weeks post-formula switch (at approximately 6.5 months of age)

    Proportion of participants in the experimental group versus the control group who experience symptom relapse within 2 weeks after switching to a Stage 2 formula at 6 months of age. Relapse is defined as an increase in the Total Symptom Index (TSI) of >20% compared to the value measured at 6 months of age.

  3. Change from Baseline in Gut Microbiota Diversity

    Time frame: Baseline, Week 2, and 2 weeks post-formula switch

    Assessment of changes in the alpha diversity (richness and evenness) of the gut microbiota, as measured by next-generation sequencing of 16S rRNA from stool samples.

Study contacts

Contact information is provided by the study sponsor or research team.

Xinqiong wang, MD

CONTACT

[email protected]

+8621 64370045 ext. 666101

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

  • Chengdu Women's and Children's Central Hospital
  • Wuhan Children's Hospital
  • Zhengzhou Children's Hospital, China

Registry information

Official study title

A Multicenter, Randomized Controlled Study of a Partially Hydrolyzed Whey Protein Formula in Infants With Mild Allergy.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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