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.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 172
- 试验地点
- 2
- 主要终点
- Digestive tolerance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Months 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
Digestive tolerance
时间窗: From 4 to 12 months old
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
次要结局
- Assessing infant feeding habits(At 4, 5, 6, 9 and 12 months old)
- Infant microbiota study(Stool sample collected at 4, 6 and 12 months old.)
- Assessment of intestinal health(Stool sample collected at 4, 6 and 12 months old.)
- Assessment of immune-inflammatory response(At 4, 6 and 12 months old.)
- Infant infection episodes(At 4, 5, 6, 9 and 12 months old.)
- Assessment of infant growth: weight(At 4, 5, 6, 9 and 12 months old.)
- Assessment of infant growth: lenght(At 4, 5, 6, 9 and 12 months old.)
- Assessment of infant growth: cephalic perimeter(At 4, 5, 6, 9 and 12 months old.)
- Evolution of body composition(At 4, 5, 6, 9 and 12 months old)
- Medical history(At 4 months old)
- Demographics(At 4 months old)