Evaluation of Safety, Growth, Tolerance and Effects on the Intestinal Fora of a New Milk for Healthy Infants (Pétunia)
Growth and Tolerance in New Born Fed Formula Supplemented With Alpha-Lactalbumin and Containing a Symbiotic
研究概览
详细说明
This prospective, randomized, double blind, controlled study evaluated the safety and effect on growth and tolerance to an infant formula supplemented with alpha-lactalbumin and containing a symbiotic, in term infants.
Term infants with a gestational age ranging from 37 to 42 weeks and whose parents chose formula feeding were enrolled during their first eight days of life.
Both parents provided informed written consent. Infants were randomly assigned to receive either the new test formula or a control, a regular formula adapted for term infants (Modilac®1). The control formula is formulated to meet the nutritional needs of infants.
For each neonates, neonatal parameters were collected.
5 visits took place : V1 (inclusion), V2 (randomization), V3 (1 month), V4 (3 months) and V5 (6 months). During each visit, the investigator filled in observational book the anthropometric parameters (weight, height, head circumference, BMI) and pieces of information collected 3 days before by the parents (gastrointestinal tolerance parameters, daily infant behaviour and milk consumption). Global parents' contentment was evaluated as well.
In two investigation centers, at the end of the 6th month, immuno-allergic test was realised.
Stools were collected at the end of the first and sixth month from diapers, for microbiological analysis and measurements of faecal inflammatory markers.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Angers、法国、49933
- CHU d'Angers
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Nantes、法国、44093
- Chu de Nantes
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Paris、法国、75651
- Hopital de la Pitie Salpetriere
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Paris、法国、75014
- Hôpital Saint Vincent de Paul (AP-HP)
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Term health newborn infant with gestational age ranging from 37 to 42 weeks
- Eutrophic
- Non breastfed children
- Apgar score > 5 to 7 minutes
Exclusion Criteria:
- Infant presenting a metabolic, nervous, digestive or organic disease able to interfere with study
- Evidence of protein cow milk allergy
- Infant presenting lactose intolerance
- Newborn whose parents did not provide informed consent
- Newborn currently participating in another trial
学习计划
研究是如何设计的?
设计细节
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Modilac Pétunia 1
Formula with reduced total protein concentration, enriched in alpha-lactalbumin and containing a symbiotic
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Infant formula used for non breastfed children
其他名称:
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有源比较器:Modilac 1
Regular milk
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Infant formula used for non breastfed children
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Growth Parameters
大体时间:1, 3 and 6 months
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1, 3 and 6 months
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次要结果测量
结果测量 |
大体时间 |
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Sensitization or allergy
大体时间:1, 3 and 6 months
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1, 3 and 6 months
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Atopic diseases (eczema atopic, asthma, allergic rhinitis)
大体时间:1, 3 and 6 months
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1, 3 and 6 months
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Describe the intestinal flora according to the nutrition group
大体时间:1 and 6 months
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1 and 6 months
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Clinical Tolerance
大体时间:1 and 6 months
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1 and 6 months
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合作者和调查者
赞助
调查人员
- 首席研究员:Jean Christophe Rozé, PhD、Chu de Nantes
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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