Dietary Restriction Efficiency Assessment of Different Hypoallergenic Formulas in Patients With Suspected Cow's Milk Protein Allergy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 360
- 主要终点
- The percentage of patients with significantly improved symptoms after EDA in the two groups
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Masking Description
入排标准
- 年龄范围
- 0 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •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.
研究组 & 干预措施
Amino Acid Formula Group (AAF Group)
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.
干预措施: Amino Acid Formula (AAF) (Dietary Supplement)
Extensively Hydrolyzed Formula Group (eHF Group)
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.
干预措施: Extensively Hydrolyzed Formula (eHF) (Dietary Supplement)
结局指标
主要结局
The percentage of patients with significantly improved symptoms after EDA in the two groups
时间窗: 2 weeks after enrolled
The criteria for improvement are: * A ≥50% reduction in the Diarrhea and Blood Stool Score. ② A ≥50% reduction in the CoMiSS Score. ③ Marked improvement or resolution of original gastrointestinal and skin symptoms, such as spit-up, vomiting, diarrhea, abdominal distension, abdominal pain, and reflux.
Symptom Improvement Rate After Elimination Diet Approach (EDA)
时间窗: 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.
The percentage of patients with significantly improved symptoms after EDA in the two groups
时间窗: 2 weeks after enrolled
The criteria for improvement are: * A ≥50% reduction in the Diarrhea and Blood Stool Score. ② A ≥50% reduction in the CoMiSS Score. ③ Marked improvement or resolution of original gastrointestinal and skin symptoms, such as spit-up, vomiting, diarrhea, abdominal distension, abdominal pain, and reflux.
次要结局
- The number of days it takes for the child to achieve significant improvement in symptoms(2 weeks after enrolled)
- Time to Achieve Significant Symptom Improvement(From enrollment up to 6 weeks (censored at last assessment).)
- The number of days it takes for the child to achieve significant improvement in symptoms(2 weeks after enrolled)