A Multicenter, Randomized Controlled Study of a Partially Hydrolyzed Whey Protein Formula in Infants With Mild Allergy.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 主要终点
- Overall Improvement Rate of Allergic Symptoms
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Weeks 至 20 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Partially Hydrolyzed Whey Protein Formula (Dietary Supplement)
Intact Cow's Milk Protein Formula
Infants receive an intact cow's milk protein formula during the intervention period with standard feeding guidance.
干预措施: Intact Cow's Milk Protein Formula (Dietary Supplement)
结局指标
主要结局
Overall Improvement Rate of Allergic Symptoms
时间窗: 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
次要结局
- Safety Assessment(Week 2, Week 4, Week 8, and 2 weeks post-formula switch)
- Change from Baseline in Allergy-Related Symptom Scores and Response Category(Baseline, Week 4, Week 8)