Open Labeled Randomized Clinical Trial of Introduction of a Partially Hydrolyzed Formula in Cow's Milk Protein Allergy After 6 Months of Elimination Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- compare the rate of tolerance to cow milk products among patients allocated to partially hydrolyzed formula after 6 months of milk free diet compared to those who completed 1 year of elimination
研究概览
简要总结
For Patients diagnosed as cow milk protein allergy: Elimination of cow's milk products (CMPs) for 6 months.
All infants were supplemented with Amino Acid-based Formula (AAF) (Neocate infant®/ Neocate junior®, Dannone Nutricia) for 6 months at start of elimination diet.
For mixed milk fed infants (still receiving breast milk with the formula), mothers were encouraged to continue breast-feeding while avoiding all milk and milk products from their own diet.
Intervention after completing 6 months of eliminating CMPs. The included patients were randomly assigned to one of (2 groups).
- Group I (AAF group) n= 50 Infants in this group continued with Amino Acid-based Formula for another 6 months.
- Group II (pHF group) n= 50 Infants in this group were shifted gradually to Partially-hydrolyzed whey formula (pHF) (Liptomil Plus HA infant formula. for another 6 months with continuation of elimination of cow's milk products.
They were followed up for manifestations of intolerance to pHF. Infant who showed manifestations of intolerance were returned to AAF and continued for 6 months with AAF.
Final step: Reintoduction of CMPs After 12 months of elimination of CMPs, evaluation of tolerance to whole CMPs was done by oral food challenge (OFC).
For infants who were still non-tolerant to CMPs after 12 months of elimination were followed up and re-challenged after 6 months.
详细描述
Phase Ⅰ:Initial assessment at enrollment i. Full medical history taking: with emphasis on: Personal History: Age- Sex- Order of birth- Consanguinity-Residence
Main presenting symptoms:
A- Gastrointestinal symptoms: at initial diagnosis According to the clinical presentations, following clinical diagnoses were identified GERD, FPIAP, FPIES, FPE, constipation and combination of symptoms as shown in the following table.
B- Associated systemic allergic manifestations: at initial diagnosis C- CoMiSS: Cow's Milk-related Symptom Score (CoMiSS) at presentation. CMPA diagnosis was confirmed by an elimination diet followed by an oral food challenge.
D- Course of the disease:
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
入排标准
- 年龄范围
- 7 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Artificially fed infants whether exclusively or complementary.
- •Confirmed diagnosis of CMPA based on clinical symptoms and signs and followed by withdrawal open re-challenge test
排除标准
- •Exclusively breast-fed infants.
- •Anaphylactic type.
- •Multiple food Allergies.
结局指标
主要结局
compare the rate of tolerance to cow milk products among patients allocated to partially hydrolyzed formula after 6 months of milk free diet compared to those who completed 1 year of elimination
时间窗: At the month 13 for both groups and for extra more 30 days of regular ingestion of cow's milk products
Questionnaire done to assess occurrence of following symptoms Vomiting, Hematemesis, Diarrhea (using BRISTOL scale), Constipation, Eczema, Skin rash, Perianal inflammation, weight loss in kilograms or failure to gain weight in kilograms, (Colic, Straining and marked Abdominal distension), skin rash, angioedema, and recurrent respiratory symptoms within two months of following up after milk reintroduction. If any of the previous items is present, then the patient is considered intolerant to milk. All items should be answered by (no) in order to consider the patient tolerant to milk
次要结局
- Tolerance to pHF after 6 months elimination diet(At the seventh month in the group allocated to receive pHF after six months of elimination diet)