An interventional study of Amino Acid Formula (AAF) and Extensively Hydrolyzed Formula (eHF) in Cow's Milk Protein Allergy, sponsored by Ruijin Hospital. Not yet recruiting. Open to participants aged 0 Months to 6 Months. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Ruijin Hospital · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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.
Dietary Supplement: Amino Acid Formula (AAF)
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.
Dietary Supplement: Extensively Hydrolyzed Formula (eHF)
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).
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).
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.
Time frame: 2 weeks after enrolled
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.
Time frame: From enrollment up to 6 weeks (censored at last assessment).
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.
Time frame: Assessed at OFC completion (typically 2-6 weeks after enrollment).
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.
Time frame: Baseline and at each follow-up visit (up to 6 weeks).
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Ruijin Hospital