ISRCTN37753699终止未知
A randomised controlled double-blind trial assessing Desensitisation to cow's milk, following partially or extensively hydrolysed formulae feeding REgimens, in children with Allergy to cow's Milk (the DREAM study)
试验速览
- 阶段
- 未知
- 状态
- 终止
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Visit 1 Inclusion Assessments:
- •1. Infant aged 6 to 12 months, inclusive at visit 1
- •2. Convincing medical history of IgE-mediated allergic reaction following ingestion of cow’s milk formula, as determined by trial physician
- •3. Infant fed with formula, either exclusively or mixed with breastfeeding
- •4. Weight of at least 7.5 kg
- •5. Written informed consent by parent/legal guardian prior to completing any study-related procedure
- •6. Titre of cow’s milk-specific IgE in serum, equal or higher to 2 kU/L (collected at visit 1, confirmed prior to visit 2/3), at inclusion or wheal reaction of equal or over 5mm to SPT* to CM at inclusion
- •Visit 2/3 Inclusion Assessments:
- •7. Positive result in the challenge to pHF (V2) or positive result in the challenge to CM (V3)
- •Added 17/05/2022:
- •*5 mm to either whole, fresh milk, or commercial milk extract
排除标准
- •Visit 1 Exclusion Assessments:
- •1. Unequivocal history of severe anaphylaxis to CM in the past requiring more than one dose of adrenaline
- •2. Doctor diagnosis of non-IgE-mediated allergy to cows’ milk or cows’ milk formula (eosinophilic esophagitis, gastritis, gastroenteritis, FPIES, enteropathies and proctocolitis). Worsening of pre-existing eczema due to CM consumption is not an exclusion criterion. Added 17/05/2022: Onset or worsening of pre-existing eczema due to CM consumption is not an exclusion criterion
- •3. Any significant clinical condition that may interfere with patient’s safety or the study outcomes. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological and endocrine disease
- •4. Requirement for continuous or frequent (monthly or more) intermittent use of oral corticosteroids for other conditions
- •5. Requirement for pharmacotherapy for any other clinical condition, if it could interfere with the patient’s safety or the study outcomes
- •6. Parents or guardians, who, by investigator judgment, are unlikely to comply with the study protocol for any reason (language barrier, communication issues, inability to understand procedures, etc)
- •7. History of overnight hospitalisation (only A&E attendances not included) for wheeze and/or bronchiolitis on more than one occasion
- •8. Currently participating in another clinical trial that may interfere with the patient’s safety or the study outcomes
- •Added 17/05/2022: 9. Another infant from the same household is currently participating in the study
- •Visit 2/3 Exclusion Assessments:
- •10. Severe anaphylaxis (anaphylaxis refractory to a single dose of intramuscular adrenaline) during challenge to pHF or CM
研究者
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