Status:
UNKNOWN
Whole Grain, Gluten-containing Cereal and PROBIOtics to Evaluate Digestive TOLERAance and Immuno-inflammatory Response
Lead Sponsor:
Laboratorios Ordesa
Collaborating Sponsors:
Ministerio de Ciencia e Innovación, Spain
Conditions:
Gastrointestinal Disorder
Immunologic Diseases in Children
Eligibility:
All Genders
4-4 years
Phase:
NA
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 cerea...
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 celia...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT04021303
Start Date
September 1 2019
End Date
June 1 2021
Last Update
December 16 2020
Active Locations (1)
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1
Facultad de Medicina
Granada, Spain, 18071