Whole Grain, Gluten-containing Cereal and PROBIOtics to Evaluate Digestive TOLERAance and Immuno-inflammatory Response (PROBIOTOLERA)
2020年12月14日 更新者：Laboratorios Ordesa
Study of the Initiation of Complementary Feeding With a Whole Grain, Gluten-containing Infant Cereal and PROBIOtics to Evaluate Digestive TOLERAance and Immuno-inflammatory Response at the Intestinal Level.
This study will assess the development of gastrointestinal health in terms of digestive tolerability and immune-inflammatory response at the intestinal level comparing a conventional gluten-free cereal with a new cereal with prebiotics, probiotics and a very moderate amount of gluten.
These are products adapted to infant feeding since 4 Months.
研究概览
地位
未知
详细说明
In 2008 the ESPGHAN recommended not to give gluten cereals before 4 months but not after 7 months.
Although the introduction of gluten in this window was linked to a posible preventive effect on celiac disease, the truth is that it has not been demonstrated.
In any case, high exposures to gluten since the 4 months have been associated with a higher incidence of celiac disease and current recommendations propose moderate and progressive exposure to gluten between 4 and 6 months old.
研究类型
介入性
注册 (预期的)
172
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
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Granada、西班牙、18071
- 招聘中
- Facultad de Medicina
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接触：
- Cristina Campoy, Professor
- 电话号码：607631601
- 邮箱：ccampoy@ugr.es
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接触：
- Angela Muñoz, PHd Student
- 电话号码：664090546
- 邮箱：angela.munozma@gmail.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
4个月 至 4个月 (孩子)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Healthy term infants (>37 weeks) vaginal delivery
- Adequate birth weight for gestational age (10-90 percentile)
- Infants with normal growth curve (10-90 percentile)
- Infants who were breastfeeding for at least 4 weeks, and at least half of the takes have been by breastfeeding.
- Infants aged 4 months (+/- 1 week) at the time of study inclusion no longer following breastfeeding, or mixed breastfeeding and if they are breast-feeding, no more than one shot a day.
- Availability to continue throughout the study period.
- Signature of informed consent by partents/guardians.
Exclusion Criteria:
- Infants who were born by cesarean section
- Infants born from preconception obese mothers
- Infants born from diabetic mothers or mothers with gestational diabetes
- Infants with a family history of celiac disease (parents or siblings)
- Infants who have had or have some type of allergic manifestation or allergic pathology
- Infants who have needed antibiotic treatment or have received some type of probiotic (the week before inclusion)
- Infants with malformations, diseases or conditions and physical disabilities that cause changes in growth and/or nutritional status
- Infants diagnosed with any immune system-related disease (primary immunodeficiency)
- Infants with a known allergy and/or intolerance to cow's milk protein
- Parents' inability to follow study (at the discretion of the researcher)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 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：Experimental Cereal
Experimental cereal with probiotics, prebiotic fiber and low carbohydrates through all the duration of the study.
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Cereal containing probiotics, prebiotic fiber and low carbohydrates
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有源比较器：Conventional cereal
Conventional gluten free cereal between 4 and 6 months old, and conventional gluten cereal between 7 and 12 months old.
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Gluten free conventional cereal (from 4 to 6 months old) and conventional cereal with gluten (from 7 to 12 months old)
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Digestive tolerance
大体时间：From 4 to 12 months old
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Infant Gastrointestinal Symptom Questionnaire (IGSQ) developed by Riley et al. to be completed by parents/guardians.
It contains 13 ítems.For each item there are 5 possible answers in gradation 1 to 5 points and the result is the sum of all of them with minimum scores of 13 (maximum health status) and maximum of 65
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From 4 to 12 months old
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Assessing infant feeding habits
大体时间：At 4, 5, 6, 9 and 12 months old
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Analysis of daily intake through a record of food consumption for 24 hours
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At 4, 5, 6, 9 and 12 months old
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Infant microbiota study
大体时间：Stool sample collected at 4, 6 and 12 months old.
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Composition, diversity of microbiota.
This procedure will be performed by studying samples of feces.
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Stool sample collected at 4, 6 and 12 months old.
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Assessment of intestinal health
大体时间：Stool sample collected at 4, 6 and 12 months old.
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Fecal microbiota profile (fecal pH, butyrate, propionate and acetate) determination
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Stool sample collected at 4, 6 and 12 months old.
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Assessment of immune-inflammatory response
大体时间：At 4, 6 and 12 months old.
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Record of the IgA secreted in saliva
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At 4, 6 and 12 months old.
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Infant infection episodes
大体时间：At 4, 5, 6, 9 and 12 months old.
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Specific parent-reported infant symptoms of mild respiratory, gastrointestinal, skin and oropharyngeal infections.
Parents will have a dairy to report all symptoms.
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At 4, 5, 6, 9 and 12 months old.
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Assessment of infant growth: weight
大体时间：At 4, 5, 6, 9 and 12 months old.
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Weight measurements in grams to report anthropometric measures
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At 4, 5, 6, 9 and 12 months old.
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Assessment of infant growth: lenght
大体时间：At 4, 5, 6, 9 and 12 months old.
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Lenght measurements in centimeters to report anthropometric measures
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At 4, 5, 6, 9 and 12 months old.
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Assessment of infant growth: cephalic perimeter
大体时间：At 4, 5, 6, 9 and 12 months old.
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Cephalic perimeter measurements in centimeters to report anthropometric measures
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At 4, 5, 6, 9 and 12 months old.
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Evolution of body composition
大体时间：At 4, 5, 6, 9 and 12 months old
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Anthropometric measures (brachial perimeter (mm), trichital skin folds and sub-scapular (mm) with compass lipometer)
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At 4, 5, 6, 9 and 12 months old
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Medical history
大体时间：At 4 months old
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Register of: gestational age, anthropometric measures at birth, lactation data and clinical history of interest
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At 4 months old
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Demographics
大体时间：At 4 months old
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Parents' age, parent education level, habits and parents lifestyle, home and social environment
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At 4 months old
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Cristina Campoy, Professor、Universidad de Granada
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年9月1日
初级完成 (预期的)
2021年6月1日
研究完成 (预期的)
2021年6月1日
研究注册日期
首次提交
2019年7月5日
首先提交符合 QC 标准的
2019年7月15日
首次发布 (实际的)
2019年7月16日
研究记录更新
最后更新发布 (实际的)
2020年12月16日
上次提交的符合 QC 标准的更新
2020年12月14日
最后验证
2020年12月1日
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.