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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-03

Study Completion Date

2020-11-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention group: New infant formula with synbiotics; Control group: Standard infant formula with prebiotics

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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New infant formula with synbiotics

pHP infant formula with synbiotics (test product)

Group Type EXPERIMENTAL

New infant formula with synbiotics

Intervention Type DIETARY_SUPPLEMENT

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

Standard infant formula with prebiotics

Standard (commercial) infant formula with prebiotics (control product)

Group Type ACTIVE_COMPARATOR

Standard infant formula with prebiotics

Intervention Type DIETARY_SUPPLEMENT

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

human milk

Full breastfeeding for at least 17 weeks

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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New infant formula with synbiotics

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

Intervention Type DIETARY_SUPPLEMENT

Standard infant formula with prebiotics

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Healthy Chinese term infants ≤ 44 days
2. Birth weight within normal range
3. Head circumference within normal range
4. Fully formula fed by the time of randomization OR fully breastfed and with intention to fully breastfeed until 17 weeks of age

Exclusion Criteria

\- The mothers of infants:

1. who are currently participating or will participate in any other (clinical) study involving investigational or marketed products during pregnancy and/or lactation;
2. known to have a significant medical condition that might interfere with the study or known to affect intra-uterine growth, as per investigator's clinical judgement;

\- Parents/Legally acceptable representatives/Caregivers of infants:
3. who are incapable to comply with study protocol

\- Infants:
4. who have to be fed with a special diet other than standard cow's milk based infant formula;
5. known to have current or previous illnesses/conditions which could interfere with the study products or its outcome parameters
6. known or suspected to have an allergic condition towards cow's milk, soy or fish;
7. with any history of, or current participation in any other study involving investigational or marketed products.

Maximum Eligible Age

44 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes