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The Effects of an Infant Formula Containing Probiotic CECT7210 on Gastrointestinal Health

NCT02096302 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2019-07-19

No results posted yet for this study

Summary

The purpose of this study is to determine whether an infant formula supplemented with a new probiotic CECT7210, is effective in reducing the incidence of infections, specially the gastrointestinal ones.

Conditions

  • Gastrointestinal Diseases

Interventions

DIETARY_SUPPLEMENT

Infant Formula with a novel probiotic CECT7210

Bottle-feeding with a new infant formula enriched with probiotic CECT7210 during the first 3 months of life.

DIETARY_SUPPLEMENT

Standard formula

Standard formula without probiotics

Sponsors & Collaborators

  • Harrison Clinical Research

    collaborator INDUSTRY

  • Laboratorios Ordesa

    lead INDUSTRY

Principal Investigators

  • Isabel Polanco, Professor · Hospital Universitario La Paz

  • Joaquin Escribano, Professor · Hospital Sant Joan de Reus, Reus, Spain

  • Ricardo Closa, Professor · Hospital Joan XXIII de Tarragona, Tarragona, Spain

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
90 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-11-30
Completion
2013-06-30

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 NCT02096302 on ClinicalTrials.gov