HealthyNCT02911454
Assess the Effects of Infant Formula on Infant Stool Characteristics, Behaviour and Parental Experience in Everyday Situations
A study testing Infant formula in people with Healthy, run by Nutricia Research at 16 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 hour to 6 weeks
- Conditions the study is for
- Healthy
- What is being tested?
- Infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 16 sitesin 3 countries
- Study dates
- Jul 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 6 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
Turkey (Türkiye)8 sites
Sağlık Bilimleri Üniversitesi Ankara Eğitim ve Araştırma Hastanesi
Ankara
Uludağ Üniversitesi Tıp Fakültesi
Bursa
Haseki Eğitim ve Araştırma Hastanesi
Istanbul
Istanbul Florence Nightingale Hastanesi
Istanbul
Medipol Mega Üniversite Hastanesi
Istanbul
Sağlık Bilimleri Üniversitesi Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi
Istanbul
Sağlık Bilimleri Üniversitesi Süleymaniye Kadın Doğum ve Çocuk Hastalıkları Eğitim ve Araştırma Hastanesi
Istanbul
Sağlık Bilimleri Üniversitesi Ümraniye Eğitim ve Araştırma Hastanesi
Istanbul
Austria6 sites
Private practice
Bischofshofen
Private practice
Eferding
Private practice
Hallein
Private practice
Linz
Private practice
Salzburg
Reinhold Rauscher
Salzburg
Poland2 sites
Poliklinika Ginekologiczno-Poloznicza Sp. Z.O.O Sp.K
Bialystok
Centrum Medyczne Promed
Krakow
About this study
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.
- Conditions
- Healthy
- Being tested
- Infant formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant formulaOther
| Study group | Role | What they receive |
|---|---|---|
| Healthy infants: fully or partly formula fed | Experimental | Not described Receives: Other: Infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool consistency measured by Amsterdam Stool Scale.
Will be reported in diaries completed by the parents.
Measured: 15 months
Crying time
Will be reported in diaries completed by the parents.
Measured: 15 months
Stool frequency
Will be reported in diaries completed by the parents.
Measured: 15 months
Secondary outcomes (3)
Eating behaviour
Baby Eating Behaviour Questionnaire
Measured: 15 months
Parental experience of child behaviour
PedsQL,
Measured: 15 months
Impact on family life
FamPedsQL
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Nutricia ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911454
- Sponsor's protocol ID
- EBB15YE89845
- Status last verified
- Mar 2017
- First submitted
- 30 Aug 2016
- Last updated
- 14 Sep 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assess the Effects of Infant Formula on Infant Stool Characteristics, Behaviour and Parental Experience in Everyday Situations
- ClinicalTrials.gov ID
- NCT02911454
- Acronym / sponsor ID
- EBB15YE89845
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- Jul 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 22 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy infants: fully or partly formula fed | Experimental | Other: Infant formula |
Who may qualify
- Ages
- 1 hour to 6 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infant formula | Other | Healthy infants: fully or partly formula fed |
Primary outcome
Stool consistency measured by Amsterdam Stool Scale.
Time frame: 15 months
Will be reported in diaries completed by the parents.
Crying time
Time frame: 15 months
Will be reported in diaries completed by the parents.
Stool frequency
Time frame: 15 months
Will be reported in diaries completed by the parents.
3 secondary outcomes
Eating behaviour
Time frame: 15 months
Parental experience of child behaviour
Time frame: 15 months
Impact on family life
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant formula in people with Healthy, run by Nutricia Research at 16 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Turkey (Türkiye), Austria, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool consistency measured by Amsterdam Stool Scale. (time frame: 15 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2017.