ClinicalTrials.gg
Sign In
CompletedNCT02911454Updated Sep 14, 2017

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

An interventional study of Infant formula in Healthy, sponsored by Nutricia Research. Completed at 16 sites in 3 countries. Open to participants aged 1 Hour to 6 Weeks. Per ClinicalTrials.gov, last updated 2017-09-14.

Sponsored by Nutricia Research (part of Danone) · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
252
Allocation
Not applicable
Ages
1 Hour to 6 Weeks
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Nutricia Research is the lead sponsor of 51 studies on the registry; 12 are open to participants now.

Browse Nutricia Research studies →All Danone studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Hour to 6 Weeks
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
252 participants (actual)

Study arms

  • Experimental
    Healthy infants: fully or partly formula fed

    Other: Infant formula

Interventions

  • OtherInfant formula
06

What researchers measure

Primary outcomes

  1. Stool consistency measured by Amsterdam Stool Scale.

    Will be reported in diaries completed by the parents.

    Time frame: 15 months

  2. Crying time

    Will be reported in diaries completed by the parents.

    Time frame: 15 months

  3. Stool frequency

    Will be reported in diaries completed by the parents.

    Time frame: 15 months

Secondary outcomes

  1. Eating behaviour

    Baby Eating Behaviour Questionnaire

    Time frame: 15 months

  2. Parental experience of child behaviour

    PedsQL,

    Time frame: 15 months

  3. Impact on family life

    FamPedsQL

    Time frame: 15 months

07

Study locations

16 sites
  • Private practice
    Bischofshofen, Austria
  • Private practice
    Eferding, Austria
  • Private practice
    Hallein, Austria
  • Private practice
    Linz, Austria
  • Private practice
    Salzburg, Austria
  • Reinhold Rauscher
    Salzburg, Austria
  • Poliklinika Ginekologiczno-Poloznicza Sp. Z.O.O Sp.K
    Bialystok, Poland
  • Centrum Medyczne Promed
    Krakow, Poland
  • Sağlık Bilimleri Üniversitesi Ankara Eğitim ve Araştırma Hastanesi
    Ankara, Turkey (Türkiye)
  • Uludağ Üniversitesi Tıp Fakültesi
    Bursa, Turkey (Türkiye)
  • Haseki Eğitim ve Araştırma Hastanesi
    Istanbul, Turkey (Türkiye)
  • Istanbul Florence Nightingale Hastanesi
    Istanbul, Turkey (Türkiye)
  • Medipol Mega Üniversite Hastanesi
    Istanbul, Turkey (Türkiye)
  • Sağlık Bilimleri Üniversitesi Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi
    Istanbul, Turkey (Türkiye)
  • Sağlık Bilimleri Üniversitesi Süleymaniye Kadın Doğum ve Çocuk Hastalıkları Eğitim ve Araştırma Hastanesi
    Istanbul, Turkey (Türkiye)
  • Sağlık Bilimleri Üniversitesi Ümraniye Eğitim ve Araştırma Hastanesi
    Istanbul, Turkey (Türkiye)
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2016 to primary completion in Aug 2017, 13 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 30, 2016
First posted
Sep 22, 2016
StartActual
Jul 2016
Primary completionActual
Aug 2017
CompletionActual
Aug 2017
Last update
Sep 14, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02911454
Lead sponsor
Nutricia Research
Responsible party
Sponsor
First posted
Sep 22, 2016
Start date
Jul 2016
Primary completion
Aug 2017
Completion
Aug 2017
Last update
Sep 14, 2017
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Nutricia Research →

Start the discussion