An interventional study of Feihe Extensively Hydrolyzed Formula and Nestlé Extensively Hydrolyzed Formula in Cow's Milk Protein Allergy (CMPA), sponsored by Heilongjiang Feihe Dairy Co. Ltd.. Not yet recruiting at 6 sites in China. Open to participants aged 0 Months to 5 Months. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by Heilongjiang Feihe Dairy Co. Ltd. · Not applicable, Interventional, and Prevention
This is a prospective, multi-center, randomized, open-label, active-controlled, parallel-group, non-inferiority study. The goal of this clinical trial is to evaluate the clinical efficacy and safety of an extensively hydrolyzed formula (eHF) in treating infants with mild-to-moderate cow's milk protein allergy (CMPA).
CMPA is a common condition in babies where the immune system reacts to proteins in cow's milk, causing symptoms affecting the skin (such as eczema or hives), gastrointestinal tract (such as vomiting, diarrhea, or constipation), and respiratory system (such as runny nose or wheezing).
The study plans to enroll 124 infants aged 0-5 months who have been diagnosed with mild-to-moderate CMPA by a physician based on established diagnostic criteria.
The main questions it aims to answer are:
Eligible participants will be randomly assigned (like drawing lots) in a 1:1 ratio to either the test group or the control group. The randomization process will be stratified by age: infants aged >0 to ≤2 months (targeting 40% of participants) and infants aged >2 to ≤5 months (targeting 60% of participants). A centralized interactive web response system (IWRS) will be used to ensure unbiased assignment.
Study Duration and Visits:
The study will last approximately 28 days. After the initial screening visit (V0), participants will need to visit the clinic 3 times:
What Participants Will Do:
Undergo medical assessments: At each visit (V1, V2, V3), the doctor will:
Complete parent questionnaires: At each visit, parents will:
147 studies on the registry are indexed under Milk Hypersensitivity; 26 are open to participants now.
This study's planned enrollment of 124 is above the median of 68 across 95 interventional studies indexed under Milk Hypersensitivity.
Browse Milk Hypersensitivity studies →Heilongjiang Feihe Dairy Co. Ltd. is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects must meet all of the following criteria to be eligible for participation:
Diagnosed with mild-to-moderate CMPA by a physician based on the Nowak-Wegrzyn (2019) diagnostic criteria, meeting any of the following prior to enrollment:
(a) Typical allergic symptoms + sensitization markers
Evidence of sensitization (any one of the following):
Exclusion Criteria:
Subjects meeting any of the following criteria are not eligible for participation:
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.
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.
Other: Feihe Extensively Hydrolyzed Formula
Other: Nestlé Extensively Hydrolyzed Formula
Feihe Extensively Hydrolyzed Formula： Nutritional Characteristics: Protein is extensively hydrolyzed into peptides and amino acids to reduce allergenicity. Enriched with MCT for rapid energy, DHA/ARA for neurodevelopment, and OPO for improved fatty acid and calcium absorption. Contains vitamins and minerals to meet full nutritional needs. Dosage and Administration: To be used under medical supervision. Dosage is individualized based on infant's age, weight, and clinical condition. Standard reconstitution: 3 level scoops (approx. 4.5 g/scoop) added to 90 mL of potable water. Intended as a sole source of nutrition for infants up to 6 months; for older infants, complementary foods may be added as advised by a physician.
Nestlé Extensively Hydrolyzed Formula： Nutritional Characteristics: Protein is extensively hydrolyzed into peptides and amino acids to reduce allergenicity. Enriched with MCT for rapid energy, DHA/ARA for neurodevelopment, and OPO for improved fatty acid and calcium absorption. Contains 26 vitamins and minerals to meet full nutritional needs. Dosage and Administration: To be used under medical supervision. Dosage is individualized. Standard reconstitution: 13.5 g powder (3 level scoops, approx. 4.5 g/scoop) added to 90 mL of cooled boiled water to obtain 100 mL of feed. Intended as a sole source of nutrition for infants up to 6 months with food protein allergy; for older infants, complementary foods may be added under medical guidance.
Symptom Relief Rate of Cow's Milk Protein Allergy (CMPA)
The proportion of infants showing improvement in CMPA symptoms. Effectiveness is defined as a reduction in severity from baseline for at least one scored symptom (skin, gastrointestinal, or respiratory) observed during study visits. No improvement in any symptoms or signs during the intervention is considered ineffective. The total effective rate is calculated as: (number of effective cases / total number of cases) × 100%.
Time frame: At Day 28 (allowing a window of ± 1 day)
Scoring Atopic Dermatitis (SCORAD) Score
Scoring Atopic Dermatitis (SCORAD) score assessing the severity of atopic dermatitis by combining physician assessment of lesion extent and intensity with parent-reported pruritus and sleep loss.
Time frame: Baseline, Day 14 ± 1, Day 28 ± 1
Infant Gastrointestinal Symptom Questionnaire (IGSQ) Score
Infant Gastrointestinal Symptom Questionnaire (IGSQ) total score assessing gastrointestinal symptoms including stooling, spitting up/vomiting, crying, fussiness/irritability, and gas.
Time frame: Baseline, Day 14 ± 1, Day 28 ± 1
Visual Analogue Scale (VAS) Score
Visual Analogue Scale (VAS) score assessing nasal symptoms (sneezing, rhinorrhea, nasal itching, congestion) and ocular symptoms (itching, foreign body sensation, redness, lacrimation). For infants with comorbid asthma, asthma symptoms (wheezing, coughing, shortness of breath, chest tightness) are also recorded. Based on objective symptoms and signs, the physician evaluates improvement in individual symptom scores as well as total scores for nasal, ocular, and asthma symptoms.
Time frame: Baseline, Day 14 ± 1, Day 28 ± 1
Bristol Stool Form Scale (BSFS) Score
Assessment of stool form. This scale is a 7-point visual chart featuring pictorial representations and textual descriptions of different stool forms, ranging from Type 1 (separate hard lumps) to Type 7 (watery stool).
Time frame: Baseline, Day 14 ± 1, Day 28 ± 1
Cow's Milk-related Symptom Score (CoMiSS) Score
Cow's Milk-related Symptom Score (CoMiSS) assessing gastrointestinal, skin, and respiratory symptoms associated with CMPA. It provides a reference for healthcare professionals to monitor the evolution of symptoms through assessment and quantification during the course of treatment.
Time frame: Baseline, Day 14 ± 1, Day 28 ± 1
Stool Samples Test Results
Presence of abnormalities in stool routine examination and fecal occult blood test results.
Time frame: Baseline, Day 14 ± 1, Day 28 ± 1
Growth Parameters
Change from baseline in weight (g), length (cm), head circumference (cm), growth velocity (g/day, cm/day), and Z-scores (WAZ, LAZ, HCAZ, WLZ) based on WHO growth standards.
Time frame: Baseline, Day 14 ± 1, Day 28 ± 1
Bone Mineral Density (Optional)
Change from baseline in ultrasound bone mineral density measurements (SOS value, Z-score, percentage) if performed.
Time frame: Baseline, Day 14 ± 1, Day 28 ± 1
Adverse Events and Concomitant Medications
Incidence, severity, and relationship to study product of adverse events and serious adverse events, as well as concomitant medication use, throughout the study period.
Time frame: From first dose to Day 28 ± 1
Plan to share: No
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Heilongjiang Feihe Dairy Co. Ltd.