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The Combiotic-Study

NCT02221687 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2022-01-20

No results posted yet for this study

Summary

The primary objective of this study is to demonstrate that a synbiotic formula, fed for the duration of the first year of life (infant and follow-on formula) reduces the incidence rate of episodes of infectious diarrhea in infants during the first year of life compared to a standard infant formula.

Conditions

  • Healthy Term Infants

Interventions

DIETARY_SUPPLEMENT

Synbiotic formula

Standard milk formula enriched with a prebiotic fiber and a probiotic strain

DIETARY_SUPPLEMENT

Control formula

Standard milk formula without pre and probiotic

Sponsors & Collaborators

  • Biofortis Mérieux NutriSciences

    collaborator OTHER

  • HiPP GmbH & Co. Vertrieb KG

    lead INDUSTRY

Principal Investigators

  • Hugues Piloquet, Pediatrician

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Weeks
Max Age
5 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2019-04-30
Completion
2021-04-30

Countries

  • France

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 NCT02221687 on ClinicalTrials.gov