Cow's Milk Protein Allergy (CMPA)NCT07855796
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+)
A study testing Diagnosed with or highly suspected CMPA: Extensively Hydrolyzed Formula intervention in people with Cow's Milk Protein Allergy (CMPA), run by Shanghai Teyi Yinuo Health Technology Co., Ltd. at 1 site in China.
Trial summary
This study aims to evaluate the clinical effect, as reported by physicians, of an extensively hydrolyzed formula in young children aged 1~3 years with diagnosed with or highly suspected CMPA in a real-world clinical practice setting. Read more about this study
- Who is it for?
- Ages 12 to 36 months
- Conditions the study is for
- Cow's Milk Protein Allergy (CMPA)
- What is being tested?
- Diagnosed with or highly suspected CMPA: Extensively Hydrolyzed Formula intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Nov 2026to Dec 2027
- 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 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 12 months≤ Age <36 months at enrollment.
- Born at term at 37 ~ 42 weeks of gestation, with birth weight 2,500~4,000g.
- Diagnosed with or highly suspected mild-to-moderate CMPA by a physician, meeting any of the following prior to enrollment:
- Positive serum cow's-milk-specific IgE (sIgE) >0.35 kUA/L (>0.7 kIU/L), combined with a detailed medical history; or a positive skin prick test (SPT);
- Positive result from a cow's milk protein elimination-challenge test;
- A documented medical history confirming CMPA within the 2 weeks prior to enrollment.
- Hospitalization is not required and home intervention is considered appropriate by the investigator.
- Written informed consent signed by a parent or legal guardian.
Who cannot join
- History of severe cows-milk-induced allergic reaction, such as anaphylactic shock.
- Underlying disease or history that may increase risk or affect gastrointestinal tolerance, growth, or development, including chronic systemic disease, congenital heart disease, chronic inflammatory bowel disease, malignant tumor, gastrointestinal malformation, or major congenital malformation.
- Laboratory abnormalities judged by the investigator to make participation inappropriate.
- Use of an extensively hydrolyzed formula or amino-acid formula within the preceding month.
- Participation in another interventional clinical trial within the preceding 90 days or currently.
- Inability to complete scheduled study visits
- Known intolerance to another ingredient in the study formula
- Any other condition judged inappropriate by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000
Chenwai Xiao, +8619121378960, xiaochenwai@scmc.com.cn
About this study
Official title: 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
This study aims to evaluate the clinical effect, as reported by physicians, of an extensively hydrolyzed formula in young children aged 1~3 years with diagnosed with or highly suspected CMPA in a real-world clinical practice setting. The study will also evaluate the growth parameters, stool frequency and consistency, formula intake volume, gastrointestinal tolerance (including fussiness, flatulence, colic) and sleep disturbances, and any adverse events that may arise during the intervention period. This is a prospective, single-arm study including 50 young children at 1 hospital in China. Each participant will be followed for 90 days.
Read the detailed description
Cow's milk protein allergy (CMPA) is one of the most common food allergy in infancy and early childhood. The global overall prevalence ranges from 0.5% to 3% , and in some regions it can be as high as 4.9%. Currently, there are no nationwide epidemiological survey data on CMPA in China. However, local studies conducted in Chongqing, Hangzhou, and Zhuhai have reported a prevalence of 0.83% ~ 3.5% in infants aged 0 ~ 2 years. The pathogenesis of CMPA mainly includes IgE-mediated immediate-type hypersensitivity, non-IgE-mediated delayed-type hypersensitivity, and mixed-type reactions mediated by both mechanisms. Clinical manifestations may involve multiple organs and systems, including the skin, gastrointestinal tract, and respiratory tract. Dietary avoidance of cow's milk protein continues to be the main therapeutic approach, utilizing extensively hydrolyzed or amino acid-based formulas as determined by the degree of allergy.
Ages 1 ~ 3 years represent a critical window for the persistence of allergic symptoms and disease resolution in toddlers; approximately 85% ~ 90% of children with CMPA achieve clinical tolerance by around 3 years of age. Meanwhile, the age group of 1 ~ 3 years is also a critical period for dietary transition and the establishment of immune tolerance, during which children are particularly vulnerable to nutritional deficiencies. Therefore, special attention should be given to this age group, so that early diagnosis and appropriate interventions can be implemented to mitigate the impact of the disease on growth and development.
This is a prospective, longitudinal, single-arm study conducted at 1 hospital in China. The study will enroll young children aged 1~ 3 years with diagnosed with or highly suspected CMPA. Each participant will be followed for 90 days after the initiation of the investigational product. Parents or legal guardians will complete questionnaires regarding symptoms, gastrointestinal function, and product acceptability, while investigators will record clinical symptoms and anthropometric data using an electronic case report form (eCRF).
Collected data will include:
- Sociodemographic and baseline characteristics: sex, birth weight and length, gestational age, and family history of allergy.
- Anthropometric parameters: weight, length, and head circumference.
- Clinical assessments: Modified CoMiSS, SCORAD, and BSFS scores.
- Parent-reported outcomes: IGSQ-13, FAQL-PB, BISQ scores,and acceptability/satisfaction surveys.
- Safety outcomes: adverse events and concomitant medications.
A healthy reference group will include, which underwent only the modified CoMiSS assessment without exposure to the investigational product or involvement in efficacy/safety analyses, yielding normative reference benchmarks for the healthy population.
- Conditions
- Cow's Milk Protein Allergy (CMPA)
- Being tested
- Diagnosed with or highly suspected CMPA: Extensively Hydrolyzed Formula intervention
- Keywords
- eHF, CMPA, Modified CoMiSS, SCORAD, IGSQ
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosed with or highly suspected CMPA: Extensively Hydrolyzed Formula interventionOther
- Avoidance of all foods and products containing cow's milk protein will be required;
- An individualized diet will be selected and arranged according to the young children's usual eating habits, with dietary guidance provided by the investigator based on the young children's allergic status;
- The intake of the investigational product will be recommended to be maintained at approximately 500 mL/day.
| Study group | Role | What they receive |
|---|---|---|
| Diagnosed with or highly suspected CMPA: Extensively Hydrolyzed Formula intervention | Experimental | * Avoidance of all foods and products containing cow's milk protein will be required;
* An individualized diet will be selected and arranged according to the young children's usual eating habits, with dietary guidance provided by the investigator based on the young children's allergic status;
* The intake of the investigational product will be recommended to be maintained at approximately 500 mL/day. Receives: Other: Diagnosed with or highly suspected CMPA: Extensively Hydrolyzed Formula intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in investigator-reported allergy symptom scores
Change from baseline to D30 and D90 in investigator-assessed allergy symptoms in toddlers with diagnosed with or highly suspected cow's milk protein allergy, measured using four instruments.
Measured: Baseline, Day 30 ± 5, Day 90 ± 7
Secondary outcomes (8)
Change in investigators measured or parent/caregiver-reported allergy symptom scores
Change from baseline to D30, D60 and D90 in investigators measured or parent/caregiver-reported symptoms, which will be analyzed according to improvement (reduction in score) or no improvement.
Measured: Baseline, Day 30 ± 5, Day 60 ± 7, Day 90 ± 7
Change in z-scores for weight, length/height, and head circumference
Change in z-scores for weight, length/height, and head circumference calculated according to World Health Organization (WHO) growth standards. Differences between baseline, D30 and D90 will be summarized using descriptive statistics.
Measured: Baseline, Day 30 ± 5, Day 90 ± 7
Change in stool characteristics
Parent-reported stool characteristics (consistency and color), stool frequencies and stool types will be summarized for each visit.
Measured: Baseline, Day 30 ± 5, Day 60 ± 7, Day 90 ± 7
Stool Samples Test Results
Abnormalities in routine stool examination and fecal occult blood test.
Measured: Baseline, Day 30 ± 5, Day 90 ± 7
Change in parental quality of life related to children allergy
Change in the Food Allergy Quality of Life-Parental Burden Questionnaire (FAQL-PB) score from baseline to Day 30, Day 60 and day 90. Improvement will be defined as a reduction in the total score. Descriptive statistics and frequencies of improvement will be presented.
Measured: Baseline, Day 30 ± 5, Day 60 ± 7, Day 90 ± 7
Parental satisfaction with the investigational product
Parent- or caregiver-reported satisfaction with the investigational product.
Measured: Day 90 ± 7
Dietary intake
Assessment of dietary intake, including food categories and quantities (by weight), at baseline, on Day 30, and on Day 90 of the intervention.
Measured: Baseline, Day 30 ± 5, Day 90 ± 7
Adverse Events and Concomitant Medications
Incidence, severity, and causal attribution to the study product of AEs and SAEs, together with concomitant medication use, throughout the study period.
Measured: From first intervention to Day 90 ± 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Teyi Yinuo Health Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855796
- Sponsor's protocol ID
- ESEHF2-CMPA-202601
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07855796
- Acronym / sponsor ID
- ESEHF2-CMPA-202601
- Conditions
- Cow's Milk Protein Allergy (CMPA)
- Keywords
- eHF, CMPA, Modified CoMiSS, SCORAD, IGSQ
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Teyi Yinuo Health Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Oct 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 aims to evaluate the clinical effect, as reported by physicians, of an extensively hydrolyzed formula in young children aged 1~3 years with diagnosed with or highly suspected CMPA in a real-world clinical practice setting. The study will also evaluate the growth parameters, stool frequency and consistency, formula intake volume, gastrointestinal tolerance (including fussiness, flatulence, colic) and sleep disturbances, and any adverse events that may arise during the intervention period. This is a prospective, single-arm study including 50 young children at 1 hospital in China. Each participant will be followed for 90 days.
Detailed description
Cow's milk protein allergy (CMPA) is one of the most common food allergy in infancy and early childhood. The global overall prevalence ranges from 0.5% to 3% , and in some regions it can be as high as 4.9%. Currently, there are no nationwide epidemiological survey data on CMPA in China. However, local studies conducted in Chongqing, Hangzhou, and Zhuhai have reported a prevalence of 0.83% ~ 3.5% in infants aged 0 ~ 2 years. The pathogenesis of CMPA mainly includes IgE-mediated immediate-type hypersensitivity, non-IgE-mediated delayed-type hypersensitivity, and mixed-type reactions mediated by both mechanisms. Clinical manifestations may involve multiple organs and systems, including the skin, gastrointestinal tract, and respiratory tract. Dietary avoidance of cow's milk protein continues to be the main therapeutic approach, utilizing extensively hydrolyzed or amino acid-based formulas as determined by the degree of allergy.
Ages 1 ~ 3 years represent a critical window for the persistence of allergic symptoms and disease resolution in toddlers; approximately 85% ~ 90% of children with CMPA achieve clinical tolerance by around 3 years of age. Meanwhile, the age group of 1 ~ 3 years is also a critical period for dietary transition and the establishment of immune tolerance, during which children are particularly vulnerable to nutritional deficiencies. Therefore, special attention should be given to this age group, so that early diagnosis and appropriate interventions can be implemented to mitigate the impact of the disease on growth and development.
This is a prospective, longitudinal, single-arm study conducted at 1 hospital in China. The study will enroll young children aged 1~ 3 years with diagnosed with or highly suspected CMPA. Each participant will be followed for 90 days after the initiation of the investigational product. Parents or legal guardians will complete questionnaires regarding symptoms, gastrointestinal function, and product acceptability, while investigators will record clinical symptoms and anthropometric data using an electronic case report form (eCRF).
Collected data will include:
- Sociodemographic and baseline characteristics: sex, birth weight and length, gestational age, and family history of allergy.
- Anthropometric parameters: weight, length, and head circumference.
- Clinical assessments: Modified CoMiSS, SCORAD, and BSFS scores.
- Parent-reported outcomes: IGSQ-13, FAQL-PB, BISQ scores,and acceptability/satisfaction surveys.
- Safety outcomes: adverse events and concomitant medications.
A healthy reference group will include, which underwent only the modified CoMiSS assessment without exposure to the investigational product or involvement in efficacy/safety analyses, yielding normative reference benchmarks for the healthy population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosed with or highly suspected CMPA: Extensively Hydrolyzed Formula intervention | Experimental | Other: Diagnosed with or highly suspected CMPA: Extensively Hydrolyzed Formula intervention* Avoidance of all foods and products containing cow's milk protein will be required; * An individualized diet will be selected and arranged according to the young children's usual eating habits, with dietary guidance provided by the investigator based on the young children's allergic status; * The intake of the investigational product will be recommended to be maintained at approximately 500 mL/day. |
Who may qualify
- Ages
- 12 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 12 months≤ Age <36 months at enrollment.
- Born at term at 37 ~ 42 weeks of gestation, with birth weight 2,500~4,000g.
- Diagnosed with or highly suspected mild-to-moderate CMPA by a physician, meeting any of the following prior to enrollment:
- Hospitalization is not required and home intervention is considered appropriate by the investigator.
- Written informed consent signed by a parent or legal guardian.
Key exclusion criteria (8 listed)
- History of severe cows-milk-induced allergic reaction, such as anaphylactic shock.
- Underlying disease or history that may increase risk or affect gastrointestinal tolerance, growth, or development, including chronic systemic disease, congenital heart disease, chronic inflammatory bowel disease, malignant tumor, gastrointestinal malformation, or major congenital malformation.
- Laboratory abnormalities judged by the investigator to make participation inappropriate.
- Use of an extensively hydrolyzed formula or amino-acid formula within the preceding month.
- Participation in another interventional clinical trial within the preceding 90 days or currently.
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 |
|---|---|---|
| Diagnosed with or highly suspected CMPA: Extensively Hydrolyzed Formula intervention* Avoidance of all foods and products containing cow's milk protein will be required; * An individualized diet will be selected and arranged according to the young children's usual eating habits, with dietary guidance provided by the investigator based on the young children's allergic status; * The intake of the investigational product will be recommended to be maintained at approximately 500 mL/day. | Other | Diagnosed with or highly suspected CMPA: Extensively Hydrolyzed Formula intervention |
Primary outcome
Change in investigator-reported allergy symptom scores
Time frame: Baseline, Day 30 ± 5, Day 90 ± 7
Change from baseline to D30 and D90 in investigator-assessed allergy symptoms in toddlers with diagnosed with or highly suspected cow's milk protein allergy, measured using four instruments.
8 secondary outcomes
Change in investigators measured or parent/caregiver-reported allergy symptom scores
Time frame: Baseline, Day 30 ± 5, Day 60 ± 7, Day 90 ± 7
Change in z-scores for weight, length/height, and head circumference
Time frame: Baseline, Day 30 ± 5, Day 90 ± 7
Change in stool characteristics
Time frame: Baseline, Day 30 ± 5, Day 60 ± 7, Day 90 ± 7
Stool Samples Test Results
Time frame: Baseline, Day 30 ± 5, Day 90 ± 7
Change in parental quality of life related to children allergy
Time frame: Baseline, Day 30 ± 5, Day 60 ± 7, Day 90 ± 7
Parental satisfaction with the investigational product
Time frame: Day 90 ± 7
Dietary intake
Time frame: Baseline, Day 30 ± 5, Day 90 ± 7
Adverse Events and Concomitant Medications
Time frame: From first intervention to Day 90 ± 7
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 2 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnosed with or highly suspected CMPA: Extensively Hydrolyzed Formula intervention in people with Cow's Milk Protein Allergy (CMPA), run by Shanghai Teyi Yinuo Health Technology Co., Ltd. at 1 site 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 8 inclusion and 8 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 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Qintong Duan (+8613782669477, duanqintong@mengniu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in investigator-reported allergy symptom scores (time frame: Baseline, Day 30 ± 5, Day 90 ± 7). 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 2 Oct 2026.