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Effect of a New Infant Formula With Specific Ingredients

NCT04306263 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2020-12-17

No results posted yet for this study

Summary

The purpose of this study is to test whether the addition of certain bioactive ingredients to a new infant formula (HMOs, osteopontin and probiotics) can have a favorable impact on the development of the infant's immune system in the first months of life.

Conditions

  • Infant Growth

Interventions

DIETARY_SUPPLEMENT

Enriched infant formula

Infant formula enriched with dairy ingredients: osteopontin, prebiotics and probiotics

DIETARY_SUPPLEMENT

Standard formula

Infants receiving a standard infant formula.

DIETARY_SUPPLEMENT

Breastfeeding arm

Infants exclusively or predominantly breastfed (\>75%).

Sponsors & Collaborators

  • Universidad de Granada

    collaborator OTHER

  • Laboratorios Ordesa

    lead INDUSTRY

Principal Investigators

  • Cristina Campoy, MD · EURISTIKOS Excellence Centre for Paediatric Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
2 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-02
Primary Completion
2022-09-30
Completion
2022-09-30

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 NCT04306263 on ClinicalTrials.gov