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To Investigate Effects of a New Infant Formula in Healthy Term Chinese Infants

NCT03520764 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2021-02-26

No results posted yet for this study

Summary

This study investigates the effects of a new infant formula on growth, safety, and tolerance in healthy term Chinese infants.

Screening starts after the informed consent is obtained. Infants who are less than or equal to 44 days of age and meeting all eligibility criteria will be enrolled into the study. The total duration of the study is around 12 months which includes 8 study visits.

Infants, whose mother has the intention to fully breastfeed her infant at least until 17 weeks of age will be enrolled into the breastfeeding reference group. Infants, whose mother has the intention to fully formula feed her infant as of 44 days of age at the latest, will be randomized to receive either the investigational product or control product until infants reach the age of 17 weeks. After the age of 17 weeks, infants can switch to any feeding and continue be followed up until 12 months of age.

Safety, growth and tolerance parameters will be followed and collected throughout the study.

Conditions

  • Healthy Infants

Interventions

DIETARY_SUPPLEMENT

New infant formula with synbiotics

Infants are fed with synbiotics formula for 17 weeks from the date of enrollment.

DIETARY_SUPPLEMENT

Standard infant formula with prebiotics

Infants are fed with prebiotics formula for 17 weeks from the date of enrollment.

Sponsors & Collaborators

  • Nutricia Early Life Nutrition (Shanghai) Co., Ltd

    collaborator UNKNOWN

  • Danone Nutricia

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
44 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-03
Primary Completion
2020-03-06
Completion
2020-11-09

Countries

  • China

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 NCT03520764 on ClinicalTrials.gov