Assess the Effects of Infant Formula on Infant Stool Characteristics, Behaviour and Parental Experience in Everyday Situations

Nutricia

Status

Completed

Conditions

Healthy

Treatments

Other: Infant formula

Study type

Interventional

Funder types

Industry

Identifiers

NCT02911454

EBB15YE89845

Details and patient eligibility

About

A prospective, multi-country, open label study to describe the stool characteristics and behaviour as well as the parents' experience in infants receiving a recently launched infant formula in a real life situation.

Enrollment

252 patients

Sex

All

Ages

1 hour to 6 weeks old

Volunteers

No Healthy Volunteers

Inclusion criteria

Healthy term infants, gestational age up to and including 37 weeks and 42 weeks and below. Healthy is defined as "no supervision or medical treatment by a medical specialist. Further more to be determined by HCP.
Birth weight between 2.5 - 4.5 KG (within normal range for gestational age and sex)
Infants up to 6 weeks of postnatal age (Including day 42)
Receiving exclusively or at least 1 complete infant formula feeding per day at study inclusion (retrospectively exclusively or partly formula fed)
Willingness to change from their regular infant formula to study product
Parents' or legal guardians' aged up to and including 18 years, written, informed consent.

Exclusion criteria

Infants with a congenital condition and / or previous or current illness and (or) medication that could interfere with the study
Infants with established or suspected cows milk allergy, lactose intolerance, galactosaemia or infants on a prescribed fibre free (e.g. prebiotic oligosaccharides) diet
Participation in any other studies involving investigational or marketed products concomitantly or within 2 weeks prior to entry into the study
Investigator's uncertainty about the willingness of the parents / legal guardians to comply with the protocol requirements.