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

Laboratorios Ordesa

Status: Unknown

Conditions: Immunologic Diseases in Children; Gastrointestinal Disorder

Treatments: Dietary Supplement: Conventional cereal; Dietary Supplement: Experimental cereal

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04021303

PROBIO-TOLERA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 172 estimated patients

Sex: All

Ages: 4 to 4 months old

Volunteers: Accepts 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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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172 participants in 2 patient groups

Experimental Cereal

Experimental group

Description:

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

Treatment:

Dietary Supplement: Experimental cereal

Conventional cereal

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Conventional cereal