Infant Feeding Intolerance, Mild Allergic Symptoms in Infants
Conditions
Keywords
Allergy, infant
Brief 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.
Interventions
DIETARY_SUPPLEMENTPartially 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_SUPPLEMENTIntact Cow's Milk Protein Formula
intact cow's milk protein formula during the intervention period with standard feeding guidance.
Sponsors
Ruijin Hospital
Wuhan Children's Hospital
Chengdu Women's and Children's Central Hospital
Zhengzhou Children's Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Weeks to 20 Weeks
Healthy volunteers
No
Inclusion criteria
1. Infants aged ≥12 weeks and \<20 weeks at the time of screening. 2. Gestational age ≥37 weeks. 3. Birth weight ≥2500g. 4. Presence of mild allergic symptoms (e.g., skin, gastrointestinal, or respiratory symptoms). 5. Infants who are predominantly formula-fed or mixed-fed at the time of enrollment. 6. Legal guardian has provided written informed consent and agrees to participate in the study.
Exclusion criteria
1. Diagnosed with moderate or severe food allergies, including a history of allergic conditions such as atopic dermatitis, wheezing bronchitis, or severe allergic reactions. 2. Confirmed cow's milk protein allergy. 3. Currently receiving a partially hydrolyzed formula or any other specialized formula. 4. Exclusively breastfed infants. 5. Known allergy or intolerance to the study formula. 6. Presence of severe illness (e.g., digestive, respiratory, neurological infections, other gastrointestinal diseases, gastrointestinal anatomical abnormalities, congenital malformations, or growth retardation). 7. Infants with a history of severe diseases such as heart, brain, liver, kidney, hematologic, connective tissue, endocrine diseases, or mental disorders. 8. Infants who have undergone major surgery that may impact the study outcomes. 9. Infants who have used systemic immune-modulating medications (e.g., anti-allergy drugs, corticosteroids, immunosuppressants, biological agents) within the last 2 weeks. 10. Infants who have used gastrointestinal medications (e.g., proton pump inhibitors, gastrointestinal motility agents, or digestive remedies) within the last 7 days. 11. Infants who have used probiotics within the last 7 days. 12. Parents who are unable to report the occurrence of symptoms or adhere to the study visits and protocol requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Improvement Rate of Allergic Symptoms | 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
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessment | 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. |
| Change from Baseline in Allergy-Related Symptom Scores and Response Category | 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. |
Contacts
CONTACTXinqiong wang, MD
Outcome results
None listed