Clinical trial NCT04021303: Whole Grain, Gluten-containing Cereal and PROBIOtics to Evaluate Digestive TOLERAance and Immuno-inflammatory Response
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Disorder
Immunologic Diseases in Children
Keywords: Gluten
Probiotic
Prebiotic
Lead sponsor: Laboratorios Ordesa
Sponsor class: INDUSTRY
Collaborators: name: Ministerio de Ciencia e Innovación, Spain
First posted: 2019-07-16
Enrollment: 172
Sex: ALL
Minimum age (years): 4
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Digestive tolerance
timeFrame: From 4 to 12 months old
Secondary outcomes:
measure: Assessing infant feeding habits
timeFrame: At 4, 5, 6, 9 and 12 months old
measure: Infant microbiota study
timeFrame: Stool sample collected at 4, 6 and 12 months old.
measure: Assessment of intestinal health
timeFrame: Stool sample collected at 4, 6 and 12 months old.
measure: Assessment of immune-inflammatory response
timeFrame: At 4, 6 and 12 months old.
measure: Infant infection episodes
timeFrame: At 4, 5, 6, 9 and 12 months old.
measure: Assessment of infant growth: weight
timeFrame: At 4, 5, 6, 9 and 12 months old.
measure: Assessment of infant growth: lenght
timeFrame: At 4, 5, 6, 9 and 12 months old.
measure: Assessment of infant growth: cephalic perimeter
timeFrame: At 4, 5, 6, 9 and 12 months old.
measure: Evolution of body composition
timeFrame: At 4, 5, 6, 9 and 12 months old
measure: Medical history
timeFrame: At 4 months old
measure: Demographics
timeFrame: At 4 months old
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Facultad de Medicina
Study officials:
affiliation: Universidad de Granada
name: Cristina Campoy, Professor
role: PRINCIPAL_INVESTIGATOR
References: