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

Gastrointestinal Disorder Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04021303
• Other study ID #: PROBIO-TOLERA
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: June 2021

Study information

• Verified date: December 2020
• Source: Laboratorios Ordesa
• Contact: Roser De Castellar, MD
• Phone: +34 902105243
• Email: RoserDeCastellar[@]ordesa.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 172
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Months to 4 Months

Eligibility

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)

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases
• Gastrointestinal Disorder
• Immune System Diseases
• Immunologic Diseases in Children

Intervention

Dietary Supplement:
• Experimental cereal
Cereal containing probiotics, prebiotic fiber and low carbohydrates
• Conventional cereal
Gluten free conventional cereal (from 4 to 6 months old) and conventional cereal with gluten (from 7 to 12 months old)

Locations

Country	Name	City	State
Spain	Facultad de Medicina	Granada

Sponsors (2)

Lead Sponsor	Collaborator
Laboratorios Ordesa	Ministerio de Ciencia e Innovación, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	Assessment of intestinal health	Fecal microbiota profile (fecal pH, butyrate, propionate and acetate) determination	Stool sample collected at 4, 6 and 12 months old.
Secondary	Assessment of immune-inflammatory response	Record of the IgA secreted in saliva	At 4, 6 and 12 months old.
Secondary	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.
Secondary	Assessment of infant growth: weight	Weight measurements in grams to report anthropometric measures	At 4, 5, 6, 9 and 12 months old.
Secondary	Assessment of infant growth: lenght	Lenght measurements in centimeters to report anthropometric measures	At 4, 5, 6, 9 and 12 months old.
Secondary	Assessment of infant growth: cephalic perimeter	Cephalic perimeter measurements in centimeters to report anthropometric measures	At 4, 5, 6, 9 and 12 months old.
Secondary	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
Secondary	Medical history	Register of: gestational age, anthropometric measures at birth, lactation data and clinical history of interest	At 4 months old
Secondary	Demographics	Parents' age, parent education level, habits and parents lifestyle, home and social environment	At 4 months old