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Long-term Safety and Efficacy of Prebiotic Enriched Infant Formula

NCT04441359 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2020-06-22

No results posted yet for this study

Summary

The primary objective of the present study was to evaluate the effects of long-term supplementation of an infant formula supplemented with prebiotic inulin-type oligosaccharides on immunological-health related outcomes.

Conditions

Interventions

OTHER

Supplemented formula

standard infant formula supplemented with 8 g/L prebiotic inulin-type fructans

OTHER

Standard formula

standard infant formula not supplemented with prebiotic inulin-type fructans

Sponsors & Collaborators

  • Laboratorios Ordesa

    collaborator INDUSTRY

  • European Union

    collaborator OTHER

  • Beneo-Institute

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-06-01
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • Belgium
  • Spain

Study Locations

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Entities

Diseases
Companies

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 NCT04441359 on ClinicalTrials.gov