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

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.

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.

Study Overview

• Status: Unknown
• Conditions: Gastrointestinal Disorder; Immunologic Diseases in Children
• Intervention / Treatment: Dietary supplement: Experimental cereal; Dietary supplement: Conventional cereal

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 Type: Interventional
• Enrollment (Anticipated): 172
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18071
    • Recruiting
    • Facultad de Medicina
    • Contact: Cristina Campoy, Professor; Phone Number: 607631601; Email: ccampoy@ugr.es
    • Contact: Angela Muñoz, PHd Student; Phone Number: 664090546; Email: angela.munozma@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 4 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 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	From 4 to 12 months old

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Laboratorios Ordesa
• Collaborators: Ministerio de Ciencia e Innovación, Spain
• Investigators: Principal Investigator: Cristina Campoy, Professor, Universidad de Granada

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: July 5, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (Actual): July 16, 2019

Study Record Updates

• Last Update Posted (Actual): December 16, 2020
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Prebiotic; Probiotic; Gluten
• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases; Immune System Diseases
• Other Study ID Numbers: PROBIO-TOLERA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No