PROBIOTOLERA: Whole Grain, Gluten-containing Cereal and PROBIOtics to Evaluate Digestive TOLERAance and Immuno-inflammatory Response

Sponsor

Laboratorios Ordesa (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04021303

Collaborator

Ministerio de Ciencia e Innovación, Spain (Other)

172

Enrollment

Location

Arms

Anticipated Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Disorder Immunologic Diseases in Children	Dietary Supplement: Experimental cereal Dietary Supplement: Conventional cereal	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

172 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

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.

Actual Study Start Date :

Sep 1, 2019

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Cereal Experimental cereal with probiotics, prebiotic fiber and low carbohydrates through all the duration of the study.	Dietary Supplement: Experimental cereal Cereal containing probiotics, prebiotic fiber and low carbohydrates
Active Comparator: Conventional cereal Conventional gluten free cereal between 4 and 6 months old, and conventional gluten cereal between 7 and 12 months old.	Dietary Supplement: Conventional cereal Gluten free conventional cereal (from 4 to 6 months old) and conventional cereal with gluten (from 7 to 12 months old)

Arm

Intervention/Treatment

Experimental: Experimental Cereal

Experimental cereal with probiotics, prebiotic fiber and low carbohydrates through all the duration of the study.

Dietary Supplement: Experimental cereal

Cereal containing probiotics, prebiotic fiber and low carbohydrates

Active Comparator: Conventional cereal

Conventional gluten free cereal between 4 and 6 months old, and conventional gluten cereal between 7 and 12 months old.

Dietary Supplement: Conventional cereal

Gluten free conventional cereal (from 4 to 6 months old) and conventional cereal with gluten (from 7 to 12 months old)

Outcome Measures

Primary Outcome Measures

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 Outcome 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 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
Assessment of infant growth: lenght [At 4, 5, 6, 9 and 12 months old.]
Lenght measurements in centimeters to report anthropometric measures
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Months to 4 Months

Sexes Eligible for Study:

All

Accepts 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)