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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02911454

Enrollment

252

Registered

2016-09-22

Start date

2016-07-31

Completion date

2017-08-31

Last updated

2017-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Interventions

OTHERInfant formula

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Hours to 6 Weeks

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.

Design outcomes

Primary

Measure	Time frame	Description
Stool consistency measured by Amsterdam Stool Scale.	15 months	Will be reported in diaries completed by the parents.
Crying time	15 months	Will be reported in diaries completed by the parents.
Stool frequency	15 months	Will be reported in diaries completed by the parents.

Secondary

Measure	Time frame	Description
Eating behaviour	15 months	Baby Eating Behaviour Questionnaire
Parental experience of child behaviour	15 months	PedsQL,
Impact on family life	15 months	FamPedsQL

Countries

Austria, Poland, Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026