Cow's Milk Protein Allergy (CMPA)NCT07484035
Safety and Efficacy Evaluation of an Extensively Hydrolyzed Formula in Infants With Cow's Milk Protein Allergy (CMPA)
A study testing Feihe Extensively Hydrolyzed Formula and Nestlé Extensively Hydrolyzed Formula in people with Cow's Milk Protein Allergy (CMPA), run by Heilongjiang Feihe Dairy Co. Ltd. at 6 sites in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 0 to 5 months
- Conditions the study is for
- Cow's Milk Protein Allergy (CMPA)
- What is being tested?
- Feihe Extensively Hydrolyzed Formula and Nestlé Extensively Hydrolyzed Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 6 sitesChina
- Study dates
- 5 Mar 2026to 31 Jul 2026
- 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 0 to 5 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects must meet all of the following criteria to be eligible for participation:
- Born at 37-42 weeks gestation with birth weight 2500-4000 g
- Aged 0 to 5 months at enrollment
- 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:
- Typical allergic symptoms + sensitization markers
- Symptoms: Clear allergic reactions (e.g., urticaria, vomiting, dyspnea) following exposure to cow's milk or dairy products
Show all 17Show fewer
- Evidence of sensitization (any one of the following):
- Serum cow's milk-specific IgE >0.7 kIU/L
- Serum cow's milk-specific IgE >0.35 kUA/L
- Positive skin prick test (wheal diameter ≥5 mm) (b) High-threshold serum specific IgE
- Infants aged <1 year: Cow's milk-specific IgE ≥5 kIU/L (c) Strongly positive SPT
- SPT wheal diameter ≥10 mm (regardless of age) (d) Positive oral food challenge under medical supervision
- Dietary elimination for at least 2 weeks, followed by OFC provoking immediate allergic reactions (e) Physician-confirmed diagnosis
- Physician-confirmed diagnosis of CMPA supported by medical records dated within 2 weeks
- Written informed consent voluntarily signed by at least one parent or legal guardian
- Parents or legal guardians able to understand the informed consent form and other study documents, and willing and able to comply with study requirements
- Parents or legal guardians agree not to enroll the infant in any other clinical studies during the trial period
Who cannot join
- Subjects meeting any of the following criteria are not eligible for participation:
- Recent onset of allergic symptoms due to causes other than cow's milk protein (including other food allergens, inhalant allergies, contact allergies, drug allergies, insect bite allergies, etc.)
- Use of any extensively hydrolyzed formula (eHF) or amino acid formula (AAF) for the treatment of cow's milk protein allergy within 1 month prior to enrollment
- Known intolerance to ingredients in the study formula (e.g., lactose intolerance)
- Severe cow's milk protein allergy requiring treatment with amino acid formula (AAF)
- Presence of severe congenital diseases or malformations, major organ dysfunction, genetic or metabolic disorders, or infectious diseases of the gastrointestinal tract or other sites
Show all 11Show fewer
- Growth retardation due to causes other than cow's milk protein allergy, or other significant medical conditions that, in the opinion of the investigator, may affect growth and/or development
- Need for specialized diets or feeding methods (e.g., amino acid formula, metabolic disorder formula, or tube feeding)
- Complementary foods already introduced
- Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the study
- Concurrent participation in another clinical study
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites
Beijing Jingdu Children's Hospital
Beijing, Beijing Municipality, 102208
Tao An, +8613621324860, wwaa7576@126.com
Sichuan Jinxin Xinan Women's and Children's Hospital
Chengdu, Sichuan, 610000
Shuhua Ren, +8613880856194, renshuhua@jxyl.com
Foshan Maternal and Child Health Hospital
Foshan, Guangdong, 528000
Saijun Huang, +8618038831089, tufanqie@163.com
Wuxi Maternal and Child Health Hospital
Wuxi, Jiangsu, 214000
Xinye Jiang, +8613814201725, fyjxy2110@163.com
Xiangtan County Maternal and Child Health Hospital
Xiangtan, Hunan, 411200
Fengyun Li, +8615873289995, 762185394@qq.com
Zhuhai Maternal and Child Health Hospital
Zhuhai, Guangdong, 519000
Hongjun Chen, +8613823092202, zhfy-chj@163.com
About this study
Official title: Safety and Efficacy Evaluation of Extensively Hydrolyzed Formula for Cow's Milk Protein Allergy (CMPA) in Infants and Young Children
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).
Read more
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:
- Does this new formula effectively relieve CMPA symptoms? Relief is defined as a reduction in severity from baseline for at least one scored symptom (skin, gastrointestinal, or respiratory) observed during study visits. The overall symptom relief rate at Day 28 will be calculated as: (number of effective cases / total number of cases) × 100%.
- What medical problems or side effects do infants experience when using this formula? Researchers will compare the new formula (Feihe Extensively Hydrolyzed Formula) to an already approved extensively hydrolyzed formula (a standard treatment for CMPA) to see if the new formula works as well (non-inferiority).
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:
- Visit 1 (V1, Day 0, before taking the study product): Baseline assessments
- Visit 2 (V2, Day 14 ± 1 day): Follow-up assessments
- Visit 3 (V3, Day 28 ± 1 day): Final assessments
What Participants Will Do:
- Receive study formula: At V1 and V2, researchers will provide enough formula until the next visit. At V2 and V3, parents should return any empty cans.
- Undergo medical assessments: At each visit (V1, V2, V3), the doctor will:
- Assess atopic dermatitis severity using the SCORAD tool (combining physical examination with parent-reported itching and sleep quality)
- Assess nasal and eye symptoms (and asthma symptoms, if applicable) using the VAS
- Assess gastrointestinal, skin, and respiratory symptoms using the CoMiSS
- At the final visit (V3), evaluate overall treatment effectiveness based on symptom improvement
- Have growth measurements taken: At each visit, researchers will measure the infant's weight (in grams), length (in cm), and head circumference (in cm). Growth velocity and Z-scores will be calculated.
- Complete parent questionnaires: At each visit, parents will:
- Report on the infant's itching and sleep for the SCORAD assessment
- Complete the IGSQ to assess gastrointestinal symptoms
- Use the BSFS pictures to help describe the infant's stool form
- Collect stool samples: Before each visit (V1, V2, V3), parents will collect a small stool sample (about 4-5 grams) using a provided kit. These samples will be tested for routine analysis and occult blood.
- Maintain a feeding diary: From V1 to V3, parents will keep a daily diary recording the amount of study formula consumed and any breastfeeding.
- Report health events: Inform the study team of any illnesses, discomfort, or medications the infant experiences throughout the study.
- Undergo optional bone density testing: At each visit, an ultrasound bone density measurement may be performed at the clinic's discretion.
- Conditions
- Cow's Milk Protein Allergy (CMPA)
- Being tested
- Feihe Extensively Hydrolyzed Formula, Nestlé Extensively Hydrolyzed Formula
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feihe Extensively Hydrolyzed FormulaOther
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 FormulaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Feihe Extensively Hydrolyzed Formula | Experimental | Not described Receives: Other: Feihe Extensively Hydrolyzed Formula |
| Nestlé Extensively Hydrolyzed Formula | Active comparator | Not described Receives: Other: Nestlé Extensively Hydrolyzed Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: At Day 28 (allowing a window of ± 1 day)
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline, Day 14 ± 1, Day 28 ± 1
Stool Samples Test Results
Presence of abnormalities in stool routine examination and fecal occult blood test results.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From first dose to Day 28 ± 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start5 Mar 2026 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cow's Milk Protein Allergy (CMPA)Studies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484035
- Sponsor's protocol ID
- FEIHE-INF2508-001
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 19 Mar 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 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Evaluation of Extensively Hydrolyzed Formula for Cow's Milk Protein Allergy (CMPA) in Infants and Young Children
- ClinicalTrials.gov ID
- NCT07484035
- Acronym / sponsor ID
- FEIHE-INF2508-001
- Conditions
- Cow's Milk Protein Allergy (CMPA)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Heilongjiang Feihe Dairy Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Mar 2026 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 19 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 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:
- Does this new formula effectively relieve CMPA symptoms? Relief is defined as a reduction in severity from baseline for at least one scored symptom (skin, gastrointestinal, or respiratory) observed during study visits. The overall symptom relief rate at Day 28 will be calculated as: (number of effective cases / total number of cases) × 100%.
- What medical problems or side effects do infants experience when using this formula? Researchers will compare the new formula (Feihe Extensively Hydrolyzed Formula) to an already approved extensively hydrolyzed formula (a standard treatment for CMPA) to see if the new formula works as well (non-inferiority).
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:
- Visit 1 (V1, Day 0, before taking the study product): Baseline assessments
- Visit 2 (V2, Day 14 ± 1 day): Follow-up assessments
- Visit 3 (V3, Day 28 ± 1 day): Final assessments
What Participants Will Do:
- Receive study formula: At V1 and V2, researchers will provide enough formula until the next visit. At V2 and V3, parents should return any empty cans.
- Undergo medical assessments: At each visit (V1, V2, V3), the doctor will:
- Assess atopic dermatitis severity using the SCORAD tool (combining physical examination with parent-reported itching and sleep quality)
- Assess nasal and eye symptoms (and asthma symptoms, if applicable) using the VAS
- Assess gastrointestinal, skin, and respiratory symptoms using the CoMiSS
- At the final visit (V3), evaluate overall treatment effectiveness based on symptom improvement
- Have growth measurements taken: At each visit, researchers will measure the infant's weight (in grams), length (in cm), and head circumference (in cm). Growth velocity and Z-scores will be calculated.
- Complete parent questionnaires: At each visit, parents will:
- Report on the infant's itching and sleep for the SCORAD assessment
- Complete the IGSQ to assess gastrointestinal symptoms
- Use the BSFS pictures to help describe the infant's stool form
- Collect stool samples: Before each visit (V1, V2, V3), parents will collect a small stool sample (about 4-5 grams) using a provided kit. These samples will be tested for routine analysis and occult blood.
- Maintain a feeding diary: From V1 to V3, parents will keep a daily diary recording the amount of study formula consumed and any breastfeeding.
- Report health events: Inform the study team of any illnesses, discomfort, or medications the infant experiences throughout the study.
- Undergo optional bone density testing: At each visit, an ultrasound bone density measurement may be performed at the clinic's discretion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feihe Extensively Hydrolyzed Formula | Experimental | Other: Feihe Extensively Hydrolyzed Formula |
| Nestlé Extensively Hydrolyzed Formula | Active comparator | Other: Nestlé Extensively Hydrolyzed Formula |
Who may qualify
- Ages
- 0 to 5 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (17 listed)
- Born at 37-42 weeks gestation with birth weight 2500-4000 g
- Aged 0 to 5 months at enrollment
- 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:
- Symptoms: Clear allergic reactions (e.g., urticaria, vomiting, dyspnea) following exposure to cow's milk or dairy products
- Evidence of sensitization (any one of the following):
Key exclusion criteria (11 listed)
- Recent onset of allergic symptoms due to causes other than cow's milk protein (including other food allergens, inhalant allergies, contact allergies, drug allergies, insect bite allergies, etc.)
- Use of any extensively hydrolyzed formula (eHF) or amino acid formula (AAF) for the treatment of cow's milk protein allergy within 1 month prior to enrollment
- Known intolerance to ingredients in the study formula (e.g., lactose intolerance)
- Severe cow's milk protein allergy requiring treatment with amino acid formula (AAF)
- Presence of severe congenital diseases or malformations, major organ dysfunction, genetic or metabolic disorders, or infectious diseases of the gastrointestinal tract or other sites
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 |
|---|---|---|
| Feihe Extensively Hydrolyzed FormulaFeihe 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. | Other | Feihe Extensively Hydrolyzed Formula |
| Nestlé Extensively Hydrolyzed FormulaNestlé 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. | Other | Nestlé Extensively Hydrolyzed Formula |
Primary outcome
Symptom Relief Rate of Cow's Milk Protein Allergy (CMPA)
Time frame: At Day 28 (allowing a window of ± 1 day)
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%.
9 secondary outcomes
Scoring Atopic Dermatitis (SCORAD) Score
Time frame: Baseline, Day 14 ± 1, Day 28 ± 1
Infant Gastrointestinal Symptom Questionnaire (IGSQ) Score
Time frame: Baseline, Day 14 ± 1, Day 28 ± 1
Visual Analogue Scale (VAS) Score
Time frame: Baseline, Day 14 ± 1, Day 28 ± 1
Bristol Stool Form Scale (BSFS) Score
Time frame: Baseline, Day 14 ± 1, Day 28 ± 1
Cow's Milk-related Symptom Score (CoMiSS) Score
Time frame: Baseline, Day 14 ± 1, Day 28 ± 1
Stool Samples Test Results
Time frame: Baseline, Day 14 ± 1, Day 28 ± 1
Growth Parameters
Time frame: Baseline, Day 14 ± 1, Day 28 ± 1
Bone Mineral Density (Optional)
Time frame: Baseline, Day 14 ± 1, Day 28 ± 1
Adverse Events and Concomitant Medications
Time frame: From first dose to Day 28 ± 1
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 19 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Cow's Milk Protein Allergy (CMPA)
Not yet recruiting
TeriFort 1+ Study: Efficacy and Safety of an Extensively Hydrolyzed Formula in the Management of Cow's Milk Protein Allergy in Young Children: A Prospective, Single-Arm Interventional Study (TeriFort 1+)
Cow's Milk Protein Allergy (CMPA)
RecruitingObservational study
SMASH: Study to Evaluate the Clinical Efficacy of an Extensively Hydrolysed Infant Formula With Synbiotics and a Human Milk Oligosaccharide (HMO) in Infants With Cow's Milk Protein Allergy (CMPA)
Cow's Milk Protein Allergy (CMPA), Food Hypersensitivity
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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feihe Extensively Hydrolyzed Formula and Nestlé Extensively Hydrolyzed Formula in people with Cow's Milk Protein Allergy (CMPA), run by Heilongjiang Feihe Dairy Co. Ltd. at 6 sites in China.
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 17 inclusion and 11 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 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Shaojie Pang (+8613001298033, pangshaojie@feihe.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Relief Rate of Cow's Milk Protein Allergy (CMPA) (time frame: At Day 28 (allowing a window of ± 1 day)). 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 19 Mar 2026.