Symptoms Based Awareness Confirmation Study - CoMiSS Validation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 10
- 主要终点
- The accuracy in terms of the Area Under Curve (AUC) of the Receiver Operating Characteristic (ROC) curve of the change in CoMiSS.
研究概览
简要总结
The Cow's Milk-related Symptom Score (CoMiSS) tool has been developed to define a score to recognize cow's milk related symptoms in infants and young children.
Many infants and toddlers with symptoms that can be related to intake of cow's milk and cow's milk protein allergy (CMPA) are often not diagnosed due to the lack of specific markers.
The goal of this trial is to validate the CoMiSS tool in infants suspected of CMPA and investigate if the CoMiSS tool could be an alternative to the open challenge test needed to confirm the diagnosis of Cow Milk Protein Allergy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female infant aged up to 6 months old
- •Has been fed exclusively on cow's milk infant formula for at least one week
- •Has CMPA symptoms that have been present for at least one week, and that developed within the first two months of starting cow's milk infant formula
- •In the opinion of the investigator, requires a two week elimination diet with Amino Acid Formula (AAF).
- •Had a gestational age at birth of 37 to 42 weeks
- •Had a birthweight of 2500 g to 4500 g
- •Informed consent signed by both parents, liable parent or legal guardian (if applicable).
排除标准
- •Has ever received either an extensively hydrolysed infant formula or an AAF prior to enrolment
- •Has a fever above 38.5°C at enrolment
- •Has ever experienced a medically diagnosed serious anaphylactic reaction
- •Use of antibiotic drugs at enrolment. Infants may be enrolled if antibiotics have been stopped at least 7 days prior to enrolment. (Antibiotic treatment can be initiated during the study if an infant develops a condition after enrolment that requires antibiotic treatment).
- •Infant with a health condition or family situation that makes the infant unsuitable to participate in the trial according to the opinion of the investigator
- •Infant or infant's carers are unable to comply with trial procedures
- •Currently participating or has participated in another clinical trial within 4 weeks prior to trial start.
研究组 & 干预措施
CoMiSS
Measure of CoMiSS followed by two weeks eviction Cow's milk protein diet and second CoMiSS measurement.
干预措施: CoMiSS questionnaire (Other)
结局指标
主要结局
The accuracy in terms of the Area Under Curve (AUC) of the Receiver Operating Characteristic (ROC) curve of the change in CoMiSS.
时间窗: baseline, Week 2
次要结局
- CoMiSS and component scores(baseline, Week 2, Week 4)
- Family history of atopy(baseline)
- Anthropometric measurements(baseline)
- Volume intake of Alfamino formula every day(baseline, week 2)
- Method of delivery at birth(baseline)
- Compliance to elimination diet(week 2)
- Physician's assessment of the likelihood that a subject has CMPA(baseline, week 2)
- The result of Oral food Challenge (OFC)(week 2, Week 4)