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

Not Applicable

• Conditions: Gastrointestinal Disorder; Immunologic Diseases in Children
• Interventions: Dietary Supplement: Experimental cereal; Dietary Supplement: Conventional cereal

• Registration Number: NCT04021303
• Lead Sponsor: Laboratorios Ordesa

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.

Study Timeline

• Study First Submitted: 2019-07-05
• Study First Submitted QC: 2019-07-15
• Study First Posted: 2019-07-16
• Study Start: 2019-09-01
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-14
• Last Update Posted: 2020-12-16
• Primary Completion: 2021-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 172

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Cereal	Experimental cereal	Experimental cereal with probiotics, prebiotic fiber and low carbohydrates through all the duration of the study.
Conventional cereal	Conventional cereal	Conventional gluten free cereal between 4 and 6 months old, and conventional gluten cereal between 7 and 12 months old.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Facultad de Medicina; 🇪🇸 Granada, Spain