The Evaluation of the Effects of an Extensive Casein Hydrolysate Containing the Probiotic Lactobacillus Rhamnosus GG as a Possible Step Down Approach Able to Stimulate the Acquisition of Immunological Tolerance Compared to an Amino Acid Formula in Children Affected by Cow's Milk Protein Allergy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Evaluation of the tolerance rate of EHCF+LGG in CMA children treated with AAF
研究概览
简要总结
Cow's milk allergy (CMA) affects up to 3% of European children. In the absence of an alternative to cow's milk, the management of CMA is based on the use of safe, affordable and nutritionally adequate formulas. In Scientific Societies Guidelines, extensively hydrolyzed casein formula (EHCF) is considered as safe first line approach for the treatment of children with CMA, whereas amino acid-based formula (AAF) is considered as second line strategy in children reacting to EHCF or as first line approach in children with CMA-induced anaphylaxis.
Few and not recent studies, involving a poorly characterized study population, suggested that up to 10% of CMA children could react to the extensively hydrolysed formulas.
It has been demonstrated that EHCF supplemented with L.rhamnosus GG (LGG) maintains hypoallergenic status and that is able to accelerate oral tolerance acquisition in children with CMA comparing with other formulas.
The purpose of this study is to investigate the feasibility of a "step-down" approach in children affected by Immunoglobulin E (IgE)-mediated CMA with the aim to evaluate the effects of EHCF + LGG on oral tolerance acquisition and on immune response and gut microbiota shaping.
详细描述
60 Immunoglobulin E-mediated CMA children, consecutively observed at tertiary Centers for Food Allergy, who will meet the inclusion criteria will be invited to participate to the study. Anamnestic, demographic, anthropometric and clinical data, as well as information on socio-demographic factors, family and living conditions, parental history of allergic diseases, number of siblings, and pet ownership will be obtained from the parents of each infant and recorded in a clinical database.
Then in all subjects an oral food challenge with EHCF + LGG will be performed. Only subjects with negative oral food challenge will be randomly allocated to one of the two groups of dietary interventions for a 12 months follow up period: group 1 received AAF , and group 2 received EHCF + LGG.
Effective use of the formula will be evaluated during the study by dieticians counselling parents about issues that could arise during the elimination diet. Parents or caregivers will be asked to keep a daily record of formula use. The amount prepared (millimetres of water and number of formula spoons) and amount left after each consumption will be recorded in a diary to assess the amount consumed by the child.
At enrolment, after 6 and 12 months body growth will be assessed by body weight, body length and head circumference measured at enrolment, after 6 and 12 months of follow-up with reference to growth charts. Unscheduled visits will be made if necessary.
In addition at enrolment, after 6 and 12 months, the investigators will perform:
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 0 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants aged <6 months
- •sure diagnosis of IgE-mediated CMA confirmed by positive oral food challenge for cow's milk and or blood Cow milk protein specific IgE>0.1kiloUnits/Liter and/or Skin Prick Testing (SPT) for milk wheal size ≥ 3mm
- •children receiving AAF for at least 4 weeks
- •full and stable remission of CMA symptoms.
排除标准
- •Infant aged > 6 months,
- •CMP-induced anaphylaxis,
- •evidence of non-IgE-mediated CMA,
- •other food allergies,
- •other allergic diseases,
- •eosinophilic disorders of the gastrointestinal tract,
- •chronic systemic diseases,
- •congenital cardiac defects,
- •active tuberculosis,
- •autoimmune diseases,
- •immunodeficiency,
- •chronic inflammatory bowel diseases,
- •celiac disease,
- •cystic fibrosis,
- •metabolic diseases,
- •malignancy,
- •chronic pulmonary diseases,
- •malformations of the gastrointestinal and/or respiratory tract,
- •administration of prebiotics or probiotics during the 4 weeks before enrolment,
- •use of systemic antibiotics or anti-mycotic drugs during 4 weeks before study entry;
- •investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements;
- •participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
结局指标
主要结局
Evaluation of the tolerance rate of EHCF+LGG in CMA children treated with AAF
时间窗: after the first oral food challenge, i.e. after 7-15 days after inclusion
tolerance to extensively hydrolyzed casein formula, i.e. the ability to eat EHCF formula (at least 100 ml/day) without sign and symptoms related to allergy
次要结局
- body growth comparing the two groups(after 6 and 12 months of intervention)
- Changing in allergological screening test comparing the two groups(after 6 and 12 months of intervention)
- Changing in immunoglobulin comparing the two groups(after 6 and 12 months of intervention)
- Changing in immune status comparing the two groups(after 6 and 12 months of intervention)
- Immune tolerance acquisition to cow milk in children treated with EHCF + LGG comparing with children assuming AAF, i.e. the ability to eat cow milk (at least 100 ml/day)(after 12 months of intervention)
- auxological parameters comparing the two groups(after 6 and 12 months of intervention)
- Changing in immune response comparing the two groups(after 6 and 12 months of intervention)
- Changing in gut microbiota composition comparing the two groups(after 6 and 12 months of intervention)
- Changing in short chain fatty acids comparing the two groups(after 6 and 12 months of intervention)
研究者
Roberto Berni Canani, MD, PhD
MD, PhD, Head of Pediatric Allergology
Federico II University