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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gastrointestinal Disorder
- Sponsor
- Laboratorios Ordesa
- Enrollment
- 172
- Locations
- 1
- Primary Endpoint
- Digestive tolerance
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Digestive tolerance
Time Frame: 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
Secondary Outcomes
- 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)