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

Gastrointestinal Disorder Clinical Trial

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.

Status Recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT04021303
• Study type: Interventional
• Source: Laboratorios Ordesa
• Contact: Roser De Castellar, MD
• Phone: +34 902105243
• Email: RoserDeCastellar@ordesa.es
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2019
• Completion date: June 2021