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

Danone

Status: Completed

Conditions: Healthy Infants

Treatments: Dietary Supplement: New infant formula with synbiotics; Dietary Supplement: Standard infant formula with prebiotics

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03520764

EBB16SI08406

Details and patient eligibility

About

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.

Enrollment: 284 patients

Sex: All

Ages: Under 44 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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284 participants in 3 patient groups

New infant formula with synbiotics

Experimental group

Description:

pHP infant formula with synbiotics (test product)

Treatment:

Dietary Supplement: New infant formula with synbiotics

Standard infant formula with prebiotics

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Standard infant formula with prebiotics

human milk

No Intervention group

Description:

Full breastfeeding for at least 17 weeks