Cow's Milk Protein AllergyNCT07199023
Dietary Restriction Efficiency Assessment in CMPA
A study testing Amino Acid Formula (AAF) and Extensively Hydrolyzed Formula (eHF) in people with Cow's Milk Protein Allergy, run by Ruijin Hospital.
Trial summary
This clinical trial aims to evaluate and compare the efficacy of amino acid formula (AAF) and extensively hydrolyzed formula (eHF) in relieving symptoms in infants suspected of cow's milk protein allergy (CMPA) during the diagnostic elimination diet phase. Read more about this study
- Who is it for?
- Ages 0 to 6 months
- Conditions the study is for
- Cow's Milk Protein Allergy
- What is being tested?
- Amino Acid Formula (AAF) and Extensively Hydrolyzed Formula (eHF)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 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 0 to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants aged 0-6 months;
- Diagnosed with suspected CMPA at the time of presentation;
- Artificially or mixed-feeding;
- Parents willing to sign a written informed consent and comply with the study - protocol.
Who cannot join
- Infants currently receiving eHF or AAF formula;
- Mixed-feeding infants whose current daily formula intake is less than 50% of their total milk intake or less than 200 ml;
- Infants who have already started adding complementary foods;
- Infants who have experienced severe food allergy symptoms such as shock, severe vomiting, etc. after taking cow's milk protein;
- Infants with clinical manifestations of systemic allergic reaction or respiratory difficulties such as acute laryngeal edema or bronchial obstruction;
- Infants who have used prednisolone or anti-allergic drugs in the past 2 weeks;
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- Infants with contraindications to eHF or AAF formula;
- Infants whose parents are unable to fully report the occurrence of possible symptoms (e.g., insufficient language skills);
- Infants with other serious diseases, including but not limited to growth retardation, metabolic disorders, kidney disease, congenital heart disease, medical conditions requiring hospitalization for more than 2 weeks, etc.;
- Infants whose mothers are unable to avoid necessary foods when mixed-feeding.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Xinqiong Wang contact
About this study
Official title: Dietary Restriction Efficiency Assessment of Different Hypoallergenic Formulas in Patients With Suspected Cow's Milk Protein Allergy
This clinical trial aims to evaluate and compare the efficacy of amino acid formula (AAF) and extensively hydrolyzed formula (eHF) in relieving symptoms in infants suspected of cow's milk protein allergy (CMPA) during the diagnostic elimination diet phase. The study will also assess treatment compliance, economic costs, and develop a CMPA screening score suitable for Chinese infants.
Eligible infants (0-6 months old) will be randomized to receive either AAF or eHF for at least 2 weeks. Symptom improvement will be evaluated, followed by an oral food challenge (OFC) to confirm CMPA diagnosis. Infants in the eHF group who do not improve may switch to AAF for further evaluation. The total duration of participation is approximately 6 to 8 weeks.
The study aims to provide evidence-based data to optimize diagnostic pathways and improve quality of life for infants with CMPA.
Read the detailed description
Cow's milk protein allergy (CMPA) is one of the most common food allergies in infants, with a prevalence of approximately 2.5-3.0% globally and 0.83-3.5% in China. Accurate diagnosis is often challenging due to the non-specific and variable symptoms, which may involve gastrointestinal, dermatologic, or respiratory systems. The current diagnostic gold standard involves an elimination diet followed by an oral food challenge (OFC). However, the choice of formula during the elimination phase may affect both symptom relief and diagnostic accuracy.
This multicenter, randomized, open-label controlled trial (DREAM-CHINA) is designed to evaluate the clinical efficacy of two hypoallergenic formulas-amino acid formula (AAF) and extensively hydrolyzed formula (eHF)-in the diagnostic elimination diet phase for infants suspected of having CMPA. The study also aims to compare the two formulas in terms of symptom improvement rate, economic burden, treatment compliance, and formula acceptance.
A total of 320 infants aged 0-6 months with suspected CMPA will be enrolled and randomized (1:1) to receive either AAF or eHF for at least 2 weeks. Infants whose symptoms significantly improve will undergo an OFC to confirm the diagnosis. Those in the eHF group who do not show improvement may switch to AAF for an additional 2 weeks before undergoing OFC.
Record the speed of symptom improvement after eliminating the diet, and evaluate the diagnosis rate of CMPA through OFC, the time of symptom improvement, safety results, and the effectiveness of symptom-based screening tools for CMPA in Chinese infants.
Throughout the study, data will be collected via electronic diaries (eCOA), clinical assessments, and standardized symptom scoring tools (e.g., CoMiSS). Regular follow-ups will monitor anthropometric growth, symptom progression, and adverse events. This study seeks to provide high-quality evidence for optimizing clinical decision-making and improving the diagnostic process for CMPA in Chinese infants.
- Conditions
- Cow's Milk Protein Allergy
- Being tested
- Amino Acid Formula (AAF), Extensively Hydrolyzed Formula (eHF)
- Keywords
- Amino Acid Formula, Extended Hydrolyzed Formula, Cow's milk protein allergy
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino Acid Formula (AAF)Dietary supplement
A formula composed of 100% free amino acids with no intact cow's milk protein. Participants will be fed AAF ad libitum according to their nutritional needs. Daily intake and symptoms will be recorded through an electronic diary (eCOA).
Extensively Hydrolyzed Formula (eHF)Dietary supplement
A formula in which cow's milk proteins are broken down into small peptides through enzymatic hydrolysis, reducing allergenicity. Participants will be fed eHF ad libitum based on their nutritional needs. Intake and symptoms will be tracked through an electronic diary (eCOA).
| Study group | Role | What they receive |
|---|---|---|
| Amino Acid Formula Group (AAF Group) | Active comparator | Participants in this group will receive an amino acid-based formula (AAF) for at least 2 weeks during the elimination diet phase. If symptoms improve, participants will undergo an oral food challenge (OFC) to confirm the diagnosis of cow's milk protein allergy (CMPA). If symptoms do not improve after 6 weeks, CMPA will be ruled out. Receives: Dietary Supplement: Amino Acid Formula (AAF) |
| Extensively Hydrolyzed Formula Group (eHF Group) | Experimental | Participants in this group will receive an extensively hydrolyzed formula (eHF) for at least 2 weeks during the elimination diet phase. If symptoms improve, OFC will be conducted to confirm CMPA diagnosis. If no improvement is observed, participants may switch to AAF for max 4 weeks of intervention. Receives: Dietary Supplement: Extensively Hydrolyzed Formula (eHF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Improvement Rate After Elimination Diet Approach (EDA)
The proportion of patients in each group who achieve significant symptom improvement at 2 weeks after starting the diagnostic EDA with different hypoallergenic formulas (amino acid formula [AAF] vs. extensively hydrolyzed formula [eHF]).
Improvement Criteria (must meet at least one of the following for ≥3 consecutive days):
- A ≥50% reduction in the Diarrhea and Blood Stool Score (baseline gastrointestinal-dominant symptoms).
- A ≥50% reduction in the Cow's Milk-related Symptom Score (CoMiSS) total score. ③ Marked improvement or resolution of original gastrointestinal and/or skin symptoms (e.g., spit-up, vomiting, diarrhea, abdominal distension, abdominal pain, reflux, eczema) as assessed by the attending physician.
Measured: 2 weeks after enrolled
Secondary outcomes (1)
Time to Achieve Significant Symptom Improvement
The number of days from the start of the intervention (EDA) until the child first meets the predefined criteria for significant symptom improvement (as defined in the primary outcome). For children who do not achieve improvement within the study period, data will be censored at the last assessment.
Measured: From enrollment up to 6 weeks (censored at last assessment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start1 Sep 2026 (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 Cow's Milk Protein AllergyStudies 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
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either an amino acid formula (AAF) or an extensively hydrolyzed formula (eHF) during the diagnostic elimination diet phase. Both groups will follow at least 2 weeks of formula-based feeding. Infants in the eHF group who do not show symptom improvement may switch to AAF for another 2 weeks. Symptom improvement will be evaluated to determine eligibility for an oral food challenge (OFC) to confirm the diagnosis of cow's milk protein allergy (CMPA).
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Women and Children's Medical Center, Beijing Children's Hospital, Peking University Third Hospital, Guangdong Provincial People's Hospital, Chengdu Women's and Children's Central Hospital, Guiyang Maternity and Child Health Care Hospital
- Responsible party
- Sponsor
- Investigators
- Chundi Xu, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199023
- Sponsor's protocol ID
- DREAM-CHINA
- Status last verified
- Aug 2026
- First submitted
- 22 Sep 2025
- Last updated
- 18 Aug 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 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Restriction Efficiency Assessment of Different Hypoallergenic Formulas in Patients With Suspected Cow's Milk Protein Allergy
- ClinicalTrials.gov ID
- NCT07199023
- Acronym / sponsor ID
- DREAM-CHINA
- Conditions
- Cow's Milk Protein Allergy
- Keywords
- Amino Acid Formula, Extended Hydrolyzed Formula, Cow's milk protein allergy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Guangzhou Women and Children's Medical Center, Beijing Children's Hospital, Peking University Third Hospital, Guangdong Provincial People's Hospital, Chengdu Women's and Children's Central Hospital, Guiyang Maternity and Child Health Care Hospital
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 Sep 2025 (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 clinical trial aims to evaluate and compare the efficacy of amino acid formula (AAF) and extensively hydrolyzed formula (eHF) in relieving symptoms in infants suspected of cow's milk protein allergy (CMPA) during the diagnostic elimination diet phase. The study will also assess treatment compliance, economic costs, and develop a CMPA screening score suitable for Chinese infants.
Eligible infants (0-6 months old) will be randomized to receive either AAF or eHF for at least 2 weeks. Symptom improvement will be evaluated, followed by an oral food challenge (OFC) to confirm CMPA diagnosis. Infants in the eHF group who do not improve may switch to AAF for further evaluation. The total duration of participation is approximately 6 to 8 weeks.
The study aims to provide evidence-based data to optimize diagnostic pathways and improve quality of life for infants with CMPA.
Detailed description
Cow's milk protein allergy (CMPA) is one of the most common food allergies in infants, with a prevalence of approximately 2.5-3.0% globally and 0.83-3.5% in China. Accurate diagnosis is often challenging due to the non-specific and variable symptoms, which may involve gastrointestinal, dermatologic, or respiratory systems. The current diagnostic gold standard involves an elimination diet followed by an oral food challenge (OFC). However, the choice of formula during the elimination phase may affect both symptom relief and diagnostic accuracy.
This multicenter, randomized, open-label controlled trial (DREAM-CHINA) is designed to evaluate the clinical efficacy of two hypoallergenic formulas-amino acid formula (AAF) and extensively hydrolyzed formula (eHF)-in the diagnostic elimination diet phase for infants suspected of having CMPA. The study also aims to compare the two formulas in terms of symptom improvement rate, economic burden, treatment compliance, and formula acceptance.
A total of 320 infants aged 0-6 months with suspected CMPA will be enrolled and randomized (1:1) to receive either AAF or eHF for at least 2 weeks. Infants whose symptoms significantly improve will undergo an OFC to confirm the diagnosis. Those in the eHF group who do not show improvement may switch to AAF for an additional 2 weeks before undergoing OFC.
Record the speed of symptom improvement after eliminating the diet, and evaluate the diagnosis rate of CMPA through OFC, the time of symptom improvement, safety results, and the effectiveness of symptom-based screening tools for CMPA in Chinese infants.
Throughout the study, data will be collected via electronic diaries (eCOA), clinical assessments, and standardized symptom scoring tools (e.g., CoMiSS). Regular follow-ups will monitor anthropometric growth, symptom progression, and adverse events. This study seeks to provide high-quality evidence for optimizing clinical decision-making and improving the diagnostic process for CMPA in Chinese infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either an amino acid formula (AAF) or an extensively hydrolyzed formula (eHF) during the diagnostic elimination diet phase. Both groups will follow at least 2 weeks of formula-based feeding. Infants in the eHF group who do not show symptom improvement may switch to AAF for another 2 weeks. Symptom improvement will be evaluated to determine eligibility for an oral food challenge (OFC) to confirm the diagnosis of cow's milk protein allergy (CMPA).
| Arm | Type | Receives |
|---|---|---|
| Amino Acid Formula Group (AAF Group) | Active comparator | Dietary Supplement: Amino Acid Formula (AAF)Participants in this group will receive an amino acid-based formula (AAF) for at least 2 weeks during the elimination diet phase. If symptoms improve, participants will undergo an oral food challenge (OFC) to confirm the diagnosis of cow's milk protein allergy (CMPA). If symptoms do not improve after 6 weeks, CMPA will be ruled out. |
| Extensively Hydrolyzed Formula Group (eHF Group) | Experimental | Dietary Supplement: Extensively Hydrolyzed Formula (eHF)Participants in this group will receive an extensively hydrolyzed formula (eHF) for at least 2 weeks during the elimination diet phase. If symptoms improve, OFC will be conducted to confirm CMPA diagnosis. If no improvement is observed, participants may switch to AAF for max 4 weeks of intervention. |
Who may qualify
- Ages
- 0 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants aged 0-6 months;
- Diagnosed with suspected CMPA at the time of presentation;
- Artificially or mixed-feeding;
- Parents willing to sign a written informed consent and comply with the study - protocol.
Key exclusion criteria (10 listed)
- Infants currently receiving eHF or AAF formula;
- Mixed-feeding infants whose current daily formula intake is less than 50% of their total milk intake or less than 200 ml;
- Infants who have already started adding complementary foods;
- Infants who have experienced severe food allergy symptoms such as shock, severe vomiting, etc. after taking cow's milk protein;
- Infants with clinical manifestations of systemic allergic reaction or respiratory difficulties such as acute laryngeal edema or bronchial obstruction;
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 |
|---|---|---|
| Amino Acid Formula (AAF)A formula composed of 100% free amino acids with no intact cow's milk protein. Participants will be fed AAF ad libitum according to their nutritional needs. Daily intake and symptoms will be recorded through an electronic diary (eCOA). | Dietary supplement | Amino Acid Formula Group (AAF Group) |
| Extensively Hydrolyzed Formula (eHF)A formula in which cow's milk proteins are broken down into small peptides through enzymatic hydrolysis, reducing allergenicity. Participants will be fed eHF ad libitum based on their nutritional needs. Intake and symptoms will be tracked through an electronic diary (eCOA). | Dietary supplement | Extensively Hydrolyzed Formula Group (eHF Group) |
Primary outcome
Symptom Improvement Rate After Elimination Diet Approach (EDA)
Time frame: 2 weeks after enrolled
The proportion of patients in each group who achieve significant symptom improvement at 2 weeks after starting the diagnostic EDA with different hypoallergenic formulas (amino acid formula [AAF] vs. extensively hydrolyzed formula [eHF]). Improvement Criteria (must meet at least one of the following for ≥3 consecutive days): * A ≥50% reduction in the Diarrhea and Blood Stool Score (baseline gastrointestinal-dominant symptoms). * A ≥50% reduction in the Cow's Milk-related Symptom Score (CoMiSS) total score. ③ Marked improvement or resolution of original gastrointestinal and/or skin symptoms (e.g., spit-up, vomiting, diarrhea, abdominal distension, abdominal pain, reflux, eczema) as assessed by the attending physician.
1 secondary outcome
Time to Achieve Significant Symptom Improvement
Time frame: From enrollment up to 6 weeks (censored at last assessment).
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.
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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.
Xinqiong Wang contact
Chundi Xu principal investigator
Ruijin Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Amino Acid Formula (AAF) and Extensively Hydrolyzed Formula (eHF) in people with Cow's Milk Protein Allergy, 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 4 inclusion and 10 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 Chundi Xu (600905 0086-021-64370045, chundixu55@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Improvement Rate After Elimination Diet Approach (EDA) (time frame: 2 weeks after enrolled). 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.