Mineral Status in Infants With Cow's Milk Protein Allergy Before and After Receiving Amino Acid-based Formula (AAF)
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- blood sample
研究概览
简要总结
This study evaluate the mineral status of infants with cow's milk protein allergy which is affected due to the elimination of milk , and the change in this mineral status after receiving amino acid - based formula for 12 weeks.
详细描述
Introduction Food allergy is defined as an adverse health effect arising from a specific Immune response that occurs following ingestion of a given food . Cow's milk protein (CMP) is the leading cause of food allergy in infants and young children younger than 3 years .Cow's milk contains at least 25 different proteins , all of which may act as antigens .
Prevelance Cow's milk protein allergy (CMPA) does seem to peak in the first year of life, with a prevalence of approximately 2% to 3% in the Infant population . This prevalence then falls to <1% in children 6 years of age and older . A few exclusively breast-fed infants may also develop clinically significant CMPA via dairy protein transfer into human breast milk .
Clinical presentation Manifestations of CMPA may involve many different organ systems mostly the skin and the gastrointestinal and respiratory tract . Skin: Urticaria, Atopic dermatitis. Gastrointestinal: perioral swelling , vomiting, regurgitation, early Satiety, diarrhea (+/-malabsorption or protein loss enteropathy) , failure to thrive, abdominal colic and persistent constipation . Respiratory: runny nose, wheezing and chronic cough. General manifestation: anaphylaxis leading to death in sensitized patient .
Diagnostic procedures Thorough medical history and physical examination. Skin prick test (SPT) and the determination of specific Ig-E in a blood sample. Allergen elimination and controlled challenge procedure. Cow's Milk-related-Symptom-Score (CoMiSS).
A Cow's Milk-related Symptom-Score (CoMiSS) is a score that considers general manifestations ,dermatological and respiratory symptoms.It was developed to be used as an awareness tool for cow's milk related symptoms. It also can be used to evaluate and quantify the evolution of symptoms during therapeutic interventions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 6 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants 1 to 6 months old.
- •Diagnosed as cow's milk protein allergic infants according to Cow's Milk-related-Symptom-Score(CoMiSS)(14).
排除标准
- •Age: more than 3 month old infants.
- •Previously diagnosed to have any gastrointestinal or systemic disease other than CMPA.
结局指标
主要结局
blood sample
时间窗: 1year
blood sample will be taken to assess/measure the mineral status(including:sodium,potassium,chloride,phosphorus,calcium,magnesium) of infants aged (1-6 months ) diagnosed as cow's milk protein allergy before receiving amino acid - based formula (at start of the study) and after receiving amino acid based formula (for 12 weeks)
次要结局
未报告次要终点
研究者
israa hosni
Principle investigator
Assiut University
