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Safety of an Infant Formula With Hydrolysed Protein in Term Infants

NCT04736082 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2021-11-26

No results posted yet for this study

Summary

A multi-centre, randomised, double-blind, parallel-group, controlled, prospective, non-inferiority intervention clinical trial is performed to assess the safety and suitability of an infant formula manufactured from extensively hydrolysed protein by showing normal growth of healthy term infants during the first 120 days of life with an optional follow up until 180 days of life.

Conditions

  • Growth

Interventions

OTHER

Intervention Group: Infant Formula with hydrolyzed protein

Infants will receive infant formula during the first 120 days of life with optional follow up until 180 days of life (intervention formula manufactured from extensively hydrolysed whey protein).

OTHER

Control Group: Infant Formula with intact protein

Infants will receive infant formula during the first 120 days of life with optional follow up until 180 days of life (control formula manufactured from intact cow's milk protein).

Sponsors & Collaborators

  • Waldkrankenhaus Protestant Hospital, Spandau

    collaborator OTHER

  • Biofortis, Merieux NutriSciences

    collaborator INDUSTRY

  • HungaroTrial

    collaborator UNKNOWN

  • HiPP GmbH & Co. Vertrieb KG

    lead INDUSTRY

Principal Investigators

  • Frank Jochum, PD Dr. med. · Evangelisches Waldkrankenhaus Spandau, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
25 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-16
Primary Completion
2021-08-31
Completion
2021-10-27

Countries

  • Germany

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 NCT04736082 on ClinicalTrials.gov