Partially Hydrolyzed Whey Protein Formula for Infants With Mild Allergy

ConditionsMild Allergic Symptoms in Infants Infant Feeding Intolerance

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age12-20

SponsorRuijin Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

160 Participants

are divided into 2 treatment groups

Group A: Partially Hydrolyzed Whey Protein FormulaExperimental treatment 1 intervention

Group B: Intact Cow's Milk Protein FormulaActive comparator 1 intervention

Trial outcomes

Primary outcomes

Overall Improvement Rate of Allergic Symptoms

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

Time frame

2 weeks after the intervention

Secondary outcomes

Safety Assessment

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.

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

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.

Time frame

Baseline, Week 4, Week 8

Other outcomes

Incidence of Skin, Gastrointestinal, and Respiratory Symptoms

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.

Time frame

Week 2, Week 4, Week 8, and 2 weeks post-formula switch

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

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.

Time frame

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

Change from Baseline in Gut Microbiota Diversity

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.

Time frame

Baseline, Week 2, and 2 weeks post-formula switch

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ruijin Hospital

Lead sponsor

Wuhan Children's Hospital

Collaborator

Chengdu Women's and Children's Central Hospital

Collaborator

Zhengzhou Children's Hospital, China

Collaborator

Source ClinicalTrials.gov

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