Gastrointestinal Disorder, Immunologic Diseases in Children
Conditions
Keywords
Gluten, Probiotic, Prebiotic
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.
Interventions
DIETARY_SUPPLEMENTExperimental cereal
Cereal containing probiotics, prebiotic fiber and low carbohydrates
DIETARY_SUPPLEMENTConventional cereal
Gluten free conventional cereal (from 4 to 6 months old) and conventional cereal with gluten (from 7 to 12 months old)
Sponsors
Ministerio de Ciencia e Innovación, Spain
Laboratorios Ordesa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Months to 4 Months
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Digestive tolerance | 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
| Measure | Time frame | Description |
|---|---|---|
| Assessment of immune-inflammatory response | At 4, 6 and 12 months old. | Record of the IgA secreted in saliva |
| Infant infection episodes | At 4, 5, 6, 9 and 12 months old. | Specific parent-reported infant symptoms of mild respiratory, gastrointestinal, skin and oropharyngeal infections. Parents will have a dairy to report all symptoms. |
| Assessment of infant growth: weight | At 4, 5, 6, 9 and 12 months old. | Weight measurements in grams to report anthropometric measures |
| Assessing infant feeding habits | At 4, 5, 6, 9 and 12 months old | Analysis of daily intake through a record of food consumption for 24 hours |
| Infant microbiota study | Stool sample collected at 4, 6 and 12 months old. | Composition, diversity of microbiota. This procedure will be performed by studying samples of feces. |
| Assessment of intestinal health | Stool sample collected at 4, 6 and 12 months old. | Fecal microbiota profile (fecal pH, butyrate, propionate and acetate) determination |
| Assessment of infant growth: cephalic perimeter | At 4, 5, 6, 9 and 12 months old. | Cephalic perimeter measurements in centimeters to report anthropometric measures |
| Evolution of body composition | At 4, 5, 6, 9 and 12 months old | Anthropometric measures (brachial perimeter (mm), trichital skin folds and sub-scapular (mm) with compass lipometer) |
| Medical history | At 4 months old | Register of: gestational age, anthropometric measures at birth, lactation data and clinical history of interest |
| Demographics | At 4 months old | Parents' age, parent education level, habits and parents lifestyle, home and social environment |
| Assessment of infant growth: lenght | At 4, 5, 6, 9 and 12 months old. | Lenght measurements in centimeters to report anthropometric measures |
Countries
Spain
Contacts
Primary ContactRoser De Castellar, MD
Outcome results
None listed