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

Primary Purpose

Gastrointestinal Disorder, Immunologic Diseases in Children

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Experimental cereal
Conventional cereal
Sponsored by
Laboratorios Ordesa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gastrointestinal Disorder focused on measuring Gluten, Probiotic, Prebiotic

Eligibility Criteria

4 Months - 4 Months (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Facultad de MedicinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Cereal

Conventional cereal

Arm Description

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

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

Outcomes

Primary Outcome Measures

Digestive tolerance
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
Analysis of daily intake through a record of food consumption for 24 hours
Infant microbiota study
Composition, diversity of microbiota. This procedure will be performed by studying samples of feces.
Assessment of intestinal health
Fecal microbiota profile (fecal pH, butyrate, propionate and acetate) determination
Assessment of immune-inflammatory response
Record of the IgA secreted in saliva
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.
Assessment of infant growth: weight
Weight measurements in grams to report anthropometric measures
Assessment of infant growth: lenght
Lenght measurements in centimeters to report anthropometric measures
Assessment of infant growth: cephalic perimeter
Cephalic perimeter measurements in centimeters to report anthropometric measures
Evolution of body composition
Anthropometric measures (brachial perimeter (mm), trichital skin folds and sub-scapular (mm) with compass lipometer)
Medical history
Register of: gestational age, anthropometric measures at birth, lactation data and clinical history of interest
Demographics
Parents' age, parent education level, habits and parents lifestyle, home and social environment

Full Information

First Posted
July 5, 2019
Last Updated
December 14, 2020
Sponsor
Laboratorios Ordesa
Collaborators
Ministerio de Ciencia e Innovación, Spain
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1. Study Identification

Unique Protocol Identification Number
NCT04021303
Brief Title
Whole Grain, Gluten-containing Cereal and PROBIOtics to Evaluate Digestive TOLERAance and Immuno-inflammatory Response
Acronym
PROBIOTOLERA
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

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Ordesa
Collaborators
Ministerio de Ciencia e Innovación, Spain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Disorder, Immunologic Diseases in Children
Keywords
Gluten, Probiotic, Prebiotic

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
172 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Cereal
Arm Type
Experimental
Arm Description
Experimental cereal with probiotics, prebiotic fiber and low carbohydrates through all the duration of the study.
Arm Title
Conventional cereal
Arm Type
Active Comparator
Arm Description
Conventional gluten free cereal between 4 and 6 months old, and conventional gluten cereal between 7 and 12 months old.
Intervention Type
Dietary Supplement
Intervention Name(s)
Experimental cereal
Intervention Description
Cereal containing probiotics, prebiotic fiber and low carbohydrates
Intervention Type
Dietary Supplement
Intervention Name(s)
Conventional cereal
Intervention Description
Gluten free conventional cereal (from 4 to 6 months old) and conventional cereal with gluten (from 7 to 12 months old)
Primary Outcome Measure Information:
Title
Digestive tolerance
Description
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
Time Frame
From 4 to 12 months old
Secondary Outcome Measure Information:
Title
Assessing infant feeding habits
Description
Analysis of daily intake through a record of food consumption for 24 hours
Time Frame
At 4, 5, 6, 9 and 12 months old
Title
Infant microbiota study
Description
Composition, diversity of microbiota. This procedure will be performed by studying samples of feces.
Time Frame
Stool sample collected at 4, 6 and 12 months old.
Title
Assessment of intestinal health
Description
Fecal microbiota profile (fecal pH, butyrate, propionate and acetate) determination
Time Frame
Stool sample collected at 4, 6 and 12 months old.
Title
Assessment of immune-inflammatory response
Description
Record of the IgA secreted in saliva
Time Frame
At 4, 6 and 12 months old.
Title
Infant infection episodes
Description
Specific parent-reported infant symptoms of mild respiratory, gastrointestinal, skin and oropharyngeal infections. Parents will have a dairy to report all symptoms.
Time Frame
At 4, 5, 6, 9 and 12 months old.
Title
Assessment of infant growth: weight
Description
Weight measurements in grams to report anthropometric measures
Time Frame
At 4, 5, 6, 9 and 12 months old.
Title
Assessment of infant growth: lenght
Description
Lenght measurements in centimeters to report anthropometric measures
Time Frame
At 4, 5, 6, 9 and 12 months old.
Title
Assessment of infant growth: cephalic perimeter
Description
Cephalic perimeter measurements in centimeters to report anthropometric measures
Time Frame
At 4, 5, 6, 9 and 12 months old.
Title
Evolution of body composition
Description
Anthropometric measures (brachial perimeter (mm), trichital skin folds and sub-scapular (mm) with compass lipometer)
Time Frame
At 4, 5, 6, 9 and 12 months old
Title
Medical history
Description
Register of: gestational age, anthropometric measures at birth, lactation data and clinical history of interest
Time Frame
At 4 months old
Title
Demographics
Description
Parents' age, parent education level, habits and parents lifestyle, home and social environment
Time Frame
At 4 months old

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
4 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roser De Castellar, MD
Phone
+34 902105243
Email
RoserDeCastellar@ordesa.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristina Campoy, Professor
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Facultad de Medicina
City
Granada
ZIP/Postal Code
18071
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Campoy, Professor
Phone
607631601
Email
ccampoy@ugr.es
First Name & Middle Initial & Last Name & Degree
Angela Muñoz, PHd Student
Phone
664090546
Email
angela.munozma@gmail.com

12. IPD Sharing Statement

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

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