About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Amino Acid Formula (AAF)
Dietary supplementA 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 supplementA 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).
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Other outcomes
Cow's Milk Protein Allergy (CMPA) Diagnosis Rate (Oral Food Challenge [OFC] Positivity Rate)
The proportion of children with positive EDA response who subsequently have a positive OFC, confirming CMPA diagnosis. Children who are directly diagnosed due to high-risk allergic reactions (without OFC) are also included in the numerator as positive cases.
Sensitivity and Validity of the CMPA Symptom Scoring System
Diagnostic performance (sensitivity, specificity) of the newly developed CMPA symptom scoring system (including CoMiSS, Diarrhea and Blood Stool Score, and Fask Score) compared against the OFC gold standard. The scoring system is used to differentiate CMPA-positive from CMPA-negative cases.
Locations
Sponsors and contacts
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Ruijin Hospital
Lead sponsor
Guangzhou Women and Children's Medical Center
Collaborator
Beijing Children's Hospital
Collaborator
Peking University Third Hospital
Collaborator
Guangdong Provincial People's Hospital
Collaborator
Chengdu Women's and Children's Central Hospital
Collaborator
Guiyang Maternity and Child Health Care Hospital
Collaborator
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