NCT07592182尚未招募不适用
Tolerance and Growth Outcomes of an Extensively Hydrolysed Anti-regurgitation Casein-based Formula in Infants With Cow's Milk Protein Allergy: a Clinical Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Lactalis
- 入组人数
- 55
研究概览
简要总结
This study is designed as multicentric, interventional, with two successive randomised, double-blind, crossovers. The aim of the study is to demonstrate the tolerance of an extensively hydrolysed anti-regurgitation casein-based formula in infants with cow's milk protein allergy. After a confirmation of the diagnostic, this demonstration will be performed with oral food challenge. Secondarily, a long term tolerance phase will be performed to get growth outcomes with a consumption of the formula compared with a non-enriched formula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 9 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 1 month and < 9 months, I
- •Exclusively formula fed and planning to be formula-fed for the duration of the study (food diversification allowed),
- •a suspicion of CMPA based on suggestive allergic symptoms
- •CoMISS score > 10
- •And/or acute allergic symptoms
- •And/or symptoms suggestive of a Food Protein-Induced Enterocolitis Syndrome (FPIES) (major criteria and <3 minor criteria as per consensus guidelines) (Nowak-Węgrzyn et al. 2017; Beaudoin et al. 2025); OR
- •a confirmed diagnosis of CMPA within the two months before inclusion:
- •IgE-mediated CMPA (documented history of allergic reaction grade ≤ 3 according to the ordinal food allergy severity score oFASS-5 (Fernández-Rivas et al. 2022) following milk protein ingestion, and sensitization to CMP: blood IgE level specific to cow milk≥ 5 kU/L, or positive skin prick test with papule with fresh cow's milk ≥ 8 mm
- •or non-IgE-mediated CMPA (documented history of eviction/reintroduction test concluding to CMPA),
- •or FPIES (major criteria and ≥3 minor criteria as per consensus guidelines (Nowak-Węgrzyn et al. 2017; Beaudoin et al. 2025), I
- •With a written informed consent signed by the father and mother or legal representative(s), I
- •With parents willing to complete questionnaires, records, and diaries associated to the study and to complete all clinical visits, I
- •With parents willing to achieve all study interventions, I
- •At least one of the legal representatives is affiliated with a social security scheme.
排除标准
- •Birthweight < 2500 g, E
- •Gestational age < 37 weeks, E
- •Breastfeeding at the time of inclusion and throughout the study period, E
- •Already fed with an AAF, or with the investigational formula EHF-AR, E
- •History of anaphylactic reaction grade 4 or 5 according to classification oFASS-5 (Fernández-Rivas et al. 2022), or of severe FPIES (previous reaction with any change in behaviour from baseline, any pallor and dehydration requiring intravenous fluids), after mammalian milk exposure, E
- •Diagnosed or reported fever and/or infectious diseases, or current systemic infections, or history of congenital infections,
- •History / diagnosis of:
- •GI disease or abnormalities (i.e. short bowel syndrome, chronic intestinal diseases, or GI malformations),
- •Or Other malformations, congenital cardiovascular, kidney, liver, pancreas, metabolic or neurological diseases,
- •Or Immunodeficiency, or chronic infection requiring long-term treatment,
- •Or Genetic diseases and chromosomal abnormalities, E
- •Suspected or confirmed food allergies or intolerances, other than CMPA, E
- •Currently enrolled in another clinical study, or in exclusion period from a previous clinical study, E
- •Whose legal representatives have psychological or linguistic incapability to sign the informed consent, E
- •Impossibility to contact the legal representatives in case of emergency.
- •After V1, the participant will be excluded from participation in this trial if he/she fulfils the following criteria:
- •No allergic symptoms following the OFC with a standard CMPF.
研究者
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