Vandenplas Yvan, Mukherjee Rajat, Dupont Christophe, Eigenmann Philippe, Høst Arne, Kuitunen Mikael, Ribes-Koninkx Carmen, Shah Neil, Szajewska Hania, von Berg Andrea, Heine Ralf G, Zhao Zheng-Yan
Kidz Health Castle, UZ Brussel, Vrije Universiteit Brussel, Brussels, Belgium.
Cytel Software Corp, Cambridge, Massachusetts, USA.
BMJ Open. 2018 May 17;8(5):e019968. doi: 10.1136/bmjopen-2017-019968.
The symptoms of cow's milk protein allergy (CMPA) in infancy can be non-specific which may delay a correct diagnosis and cause adverse clinical outcomes. The diagnosis of non-IgE-mediated CMPA is particularly complex as it involves a 2 to 4 week elimination diet followed by oral food challenge (OFC). The Cow's Milk-related Symptom Score (CoMiSS) is a clinical resource for primary healthcare providers which aims to increase awareness of CMPA symptoms to facilitate an earlier diagnosis. The aim of the present study is to assess if the CoMiSS can be used as a potential diagnostic tool in infants with suspected CMPA.
Exclusively formula-fed infants aged 0-6 months presenting with symptoms suggestive of CMPA will be included in this prospective, multicentre trial which will be conducted in 10 centres in China. All infants will commence a 2-week trial of an amino acid-based formula (AAF) while eliminating all cow milk protein from their diets. After the AAF treatment period, infants will undergo an open OFC in hospital with standard cow's milk formula, followed by an open home challenge for another 2 weeks. Clinical symptoms will be documented on standardised symptom scorecards. The CoMiSS will be determined at study entry (CoMiSS 1, before the start of the AAF), after 2 weeks (CoMiSS 2, before the OFC) and after a further period of 2 weeks or when symptoms suggestive of CMPA reappear (CoMiSS 3). Weight and length will be measured at each visit. The difference between CoMiSS 1 and 2 as a predictor of the OFC outcome will also be assessed. The diagnostic accuracy of the baseline CoMiSS will be calculated.
The study was approved by the Hunan Children's Hospital Medical Ethics Committee, Hunan, China. The findings of this trial will be submitted for publication in a peer-reviewed journal in paediatric nutrition or gastroenterology. Abstracts will be submitted to the relevant national and international conferences.
NCT03004729; Pre-results.
婴儿期牛奶蛋白过敏（CMPA）的症状可能不具有特异性，这可能会延迟正确诊断并导致不良临床后果。非IgE介导的CMPA的诊断尤为复杂，因为这涉及为期2至4周的饮食排除，随后进行口服食物激发试验（OFC）。牛奶相关症状评分（CoMiSS）是一项面向初级医疗保健提供者的临床资源，旨在提高对CMPA症状的认识，以便更早诊断。本研究的目的是评估CoMiSS是否可作为疑似CMPA婴儿的潜在诊断工具。
本前瞻性多中心试验将纳入中国10个中心的0至6个月纯配方奶喂养且出现CMPA疑似症状的婴儿。所有婴儿将开始为期2周的基于氨基酸的配方奶（AAF）试验，同时从饮食中排除所有牛奶蛋白。在AAF治疗期后，婴儿将在医院接受标准牛奶配方奶的开放式OFC，随后进行为期2周的开放式家庭激发试验。临床症状将记录在标准化症状评分卡上。CoMiSS将在研究开始时（CoMiSS 1，AAF开始前）、2周后（CoMiSS 2，OFC前）以及再过2周或出现CMPA疑似症状时（CoMiSS 3）确定。每次就诊时将测量体重和身长。还将评估CoMiSS 1和2之间的差异作为OFC结果的预测指标。将计算基线CoMiSS的诊断准确性。
本研究已获得中国湖南儿童医院医学伦理委员会批准。本试验结果将提交至儿科营养或胃肠病学领域的同行评审期刊发表。摘要将提交至相关的国内和国际会议。
NCT03004729；预结果
