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| Name | Class |
|---|---|
| Ministerio de Ciencia e InnovaciĂłn, Spain | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Cereal | Experimental | Experimental cereal with probiotics, prebiotic fiber and low carbohydrates through all the duration of the study. |
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| Conventional cereal | Active Comparator | Conventional gluten free cereal between 4 and 6 months old, and conventional gluten cereal between 7 and 12 months old. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental cereal | Dietary Supplement | Cereal containing probiotics, prebiotic fiber and low carbohydrates |
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| Measure | Description | Time Frame |
|---|---|---|
| Digestive tolerance | Infant Gastrointestinal Symptom Questionnaire (IGSQ) developed by Riley et al. to be completed by parents/guardians. It contains 13 Ătems.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 | From 4 to 12 months old |
| Measure | Description | Time Frame |
|---|---|---|
| Assessing infant feeding habits | Analysis of daily intake through a record of food consumption for 24 hours | At 4, 5, 6, 9 and 12 months old |
| Infant microbiota study | Composition, diversity of microbiota. This procedure will be performed by studying samples of feces. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roser De Castellar, MD | Contact | +34 902105243 | RoserDeCastellar@ordesa.es |
| Name | Affiliation | Role |
|---|---|---|
| Cristina Campoy, Professor | Universidad de Granada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facultad de Medicina | Recruiting | Granada | 18071 | Spain |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| Conventional cereal | Dietary Supplement | 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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| Stool sample collected at 4, 6 and 12 months old. |
| Assessment of intestinal health | Fecal microbiota profile (fecal pH, butyrate, propionate and acetate) determination | Stool sample collected at 4, 6 and 12 months old. |
| Assessment of immune-inflammatory response | Record of the IgA secreted in saliva | At 4, 6 and 12 months old. |
| Infant infection episodes | Specific parent-reported infant symptoms of mild respiratory, gastrointestinal, skin and oropharyngeal infections. Parents will have a dairy to report all symptoms. | At 4, 5, 6, 9 and 12 months old. |
| Assessment of infant growth: weight | Weight measurements in grams to report anthropometric measures | At 4, 5, 6, 9 and 12 months old. |
| Assessment of infant growth: lenght | Lenght measurements in centimeters to report anthropometric measures | At 4, 5, 6, 9 and 12 months old. |
| Assessment of infant growth: cephalic perimeter | Cephalic perimeter measurements in centimeters to report anthropometric measures | At 4, 5, 6, 9 and 12 months old. |
| Evolution of body composition | Anthropometric measures (brachial perimeter (mm), trichital skin folds and sub-scapular (mm) with compass lipometer) | At 4, 5, 6, 9 and 12 months old |
| Medical history | Register of: gestational age, anthropometric measures at birth, lactation data and clinical history of interest | At 4 months old |
| Demographics | Parents' age, parent education level, habits and parents lifestyle, home and social environment | At 4 months old |