Assess the Effects of Infant Formula on Infant Stool Characteristics, Behaviour and Parental Experience in Everyday Situations
NCT ID: NCT02911454
Last Updated: 2017-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
252 participants
INTERVENTIONAL
2016-07-31
2017-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Gastrointestinal Tolerance and Safety of an Infant Formula Containing Prebiotics, Probiotics and Postbiotics.
NCT04745455
Effect of Infant Formulas Containing a New Fat Blend or the New Fat Blend Plus Fiber in Healthy Term Infants
NCT02031003
Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula
NCT01370967
Impact of Infant Formula on Caregiver-perceived Intolerance
NCT03679234
Effect of Formula on Infant Behavior
NCT02746016
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Healthy infants: fully or partly formula fed
Infant formula
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Infant formula
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
1 Hour
6 Weeks
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nutricia Research
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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)
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EBB15YE89845
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.