NCT04021303

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

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: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 172 (estimated)
• Sponsor: Laboratorios Ordesa · Industry
• Sex: All
• Age: 4 Months – 4 Months
• Healthy volunteers: Accepted

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.

Conditions

• Gastrointestinal Disorder
• Immunologic Diseases in Children

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Experimental cereal	Cereal containing probiotics, prebiotic fiber and low carbohydrates
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)

Timeline

• Start date: 2019-09-01
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2019-07-16
• Last updated: 2020-12-16

Locations

1 site across 1 country: Spain