Mild Allergic Symptoms in InfantsNCT07449507
Partially Hydrolyzed Whey Protein Formula for Infants With Mild Allergy
A study testing Partially Hydrolyzed Whey Protein Formula and Intact Cow's Milk Protein Formula in people with Mild Allergic Symptoms in Infants and Infant Feeding Intolerance, run by Ruijin Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 20 weeks
- Conditions the study is for
- Mild Allergic Symptoms in Infants, Infant Feeding Intolerance
- What is being tested?
- Partially Hydrolyzed Whey Protein Formula and Intact Cow's Milk Protein Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized Controlled Study of a Partially Hydrolyzed Whey Protein Formula in 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.
- Being tested
- Partially Hydrolyzed Whey Protein Formula, Intact Cow's Milk Protein Formula
- Keywords
- Allergy, infant
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partially Hydrolyzed Whey Protein FormulaDietary 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 FormulaDietary supplement
intact cow's milk protein formula during the intervention period with standard feeding guidance.
| Study group | Role | What they receive |
|---|---|---|
| Partially Hydrolyzed Whey Protein Formula | Experimental | 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. Receives: Dietary Supplement: Partially Hydrolyzed Whey Protein Formula |
| Intact Cow's Milk Protein Formula | Active comparator | Infants receive an intact cow's milk protein formula during the intervention period with standard feeding guidance. Receives: Dietary Supplement: Intact Cow's Milk Protein Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks after the intervention
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, Week 4, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Allergic Symptoms in InfantsStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan Children's Hospital, Chengdu Women's and Children's Central Hospital, Zhengzhou Children's Hospital, China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449507
- Sponsor's protocol ID
- PHASE
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Controlled Study of a Partially Hydrolyzed Whey Protein Formula in Infants With Mild Allergy.
- ClinicalTrials.gov ID
- NCT07449507
- Acronym / sponsor ID
- PHASE
- Keywords
- Allergy, infant
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Wuhan Children's Hospital, Chengdu Women's and Children's Central Hospital, Zhengzhou Children's Hospital, China
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partially Hydrolyzed Whey Protein Formula | Experimental | Dietary Supplement: Partially Hydrolyzed Whey Protein FormulaInfants 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 | Active comparator | Dietary Supplement: Intact Cow's Milk Protein FormulaInfants receive an intact cow's milk protein formula during the intervention period with standard feeding guidance. |
Who may qualify
- Ages
- 12 to 20 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partially Hydrolyzed Whey Protein FormulaInfants 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 |
| Intact Cow's Milk Protein Formulaintact cow's milk protein formula during the intervention period with standard feeding guidance. | Dietary supplement | Intact Cow's Milk Protein Formula |
Primary outcome
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
2 secondary outcomes
Safety Assessment
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
Time frame: Baseline, Week 4, Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Partially Hydrolyzed Whey Protein Formula and Intact Cow's Milk Protein Formula in people with Mild Allergic Symptoms in Infants and Infant Feeding Intolerance, run by Ruijin Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinqiong wang, MD (+8621 64370045 ext. 666101, wangxq1983@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Improvement Rate of Allergic Symptoms (time frame: 2 weeks after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.