Growth of Infants Fed a New Term Infant Formula

Nestlé

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Infant formula (CF); Dietary Supplement: Infant Formula (EF)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03090360

16.07.INF

Details and patient eligibility

About

To evaluate the growth of healthy term infants fed an experimental infant formula with a prebiotic, a commercial control infant formula with a probiotic, but without a prebiotic and human breast milk

Full description

Multisite, double-blind, randomized, controlled clinical trial. The purpose of the study is to determine if infants fed a standard infant formula with a prebiotic have a weight gain in line with infants fed a standard starter infant formula without a prebiotic.

Enrollment: 349 patients

Sex: All

Ages: Under 14 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Written informed consent signed and dated
2. Infants whose parent(s)/Legally Authorized Representative (LAR) have reached the legal age of majority in Belgium
3. Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol.
4. Infants whose parent(s)/LAR are able to be contacted directly by telephone throughout the study.
5. Infants whose parent(s)/LAR have a working freezer.
6. Healthy term, singleton infant at birth.
7. At enrollment visit, post-natal age ≤ 14 days (date of birth = day 0).
8. At enrollment, birth weight ≥ 2500g and ≤ 4500g.
9. For formula-fed group, infant of parent(s)/LAR who have previously made the decision to formula feed their infant at the time of enrollment.

Exclusion criteria

1. Infants with conditions requiring infant feedings other than those specified in the protocol.
2. Infants receiving complementary foods or liquids.
3. Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results.
4. Infants who are presently receiving or have received prior to enrollment medications that could interfere with the interpretation of study results.
5. Infants or infants whose parent(s)/LAR who in the Investigator's assessment cannot be expected to comply with the protocol or with study procedures.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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349 participants in 3 patient groups, including a placebo group

Placebo comparator (Control)

Placebo Comparator group

Description:

Starter infant formula with a probiotic and without a prebiotic. Volumes of feed depend on age, weight and appetite.

Treatment:

Dietary Supplement: Infant formula (CF)

Experimental Formula (Test)

Experimental group

Description:

Starter infant formula with a probiotic and prebiotic. Volumes of feed depend on age, weight and appetite.

Treatment:

Dietary Supplement: Infant Formula (EF)

Breastfed reference group

No Intervention group

Description:

Breastfed reference group