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

NCT04021303 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2020-12-16

No results posted yet for this study

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.

Conditions

  • Gastrointestinal Disorder
  • Immunologic Diseases in Children

Interventions

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)

Sponsors & Collaborators

  • Ministerio de Ciencia e Innovación, Spain

    collaborator OTHER_GOV

  • Laboratorios Ordesa

    lead INDUSTRY

Principal Investigators

  • Cristina Campoy, Professor · Universidad de Granada

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Months
Max Age
4 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04021303 on ClinicalTrials.gov