An interventional study of Partially Hydrolyzed Whey Protein Formula and Intact Cow's Milk Protein Formula in Mild Allergic Symptoms in Infants and Infant Feeding Intolerance, sponsored by Ruijin Hospital. Not yet recruiting. Open to participants aged 12 Weeks to 20 Weeks. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Ruijin Hospital · Not applicable, Interventional, and Treatment
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.
1,055 studies on the registry are indexed under Hypersensitivity; 149 are open to participants now.
This study's planned enrollment of 160 is above the median of 73 across 691 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →Ruijin Hospital is the lead sponsor of 679 studies on the registry; 387 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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: Partially Hydrolyzed Whey Protein Formula
Infants receive an intact cow's milk protein formula during the intervention period with standard feeding guidance.
Dietary Supplement: Intact Cow's Milk 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.
intact cow's milk protein formula during the intervention period with standard feeding guidance.
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
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
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Dec 2028, 23 months later.
Of 150 non-industry interventional studies with no phase under Hypersensitivity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 43. This study's planned 23 months is close to that.
Counting every sponsor, half of 174 studies reached it within 20 months; a quarter within 5 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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