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

Healthy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02911454
• Other study ID #: EBB15YE89845
• Status: Completed
• Phase: N/A
• First received: August 30, 2016
• Last updated: September 13, 2017
• Start date: July 2016
• Est. completion date: August 2017

Study information

• Verified date: March 2017
• Source: Nutricia Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Infant formula

Locations

Country	Name	City	State
Austria	Private practice	Bischofshofen
Austria	Private practice	Eferding
Austria	Private practice	Hallein
Austria	Private practice	Linz
Austria	Private practice	Salzburg
Austria	Reinhold Rauscher	Salzburg
Poland	Poliklinika Ginekologiczno-Poloznicza Sp. Z.O.O Sp.K	Bialystok
Poland	Centrum Medyczne Promed	Krakow
Turkey	Saglik Bilimleri Üniversitesi Ankara Egitim ve Arastirma Hastanesi	Ankara
Turkey	Uludag Üniversitesi Tip Fakültesi	Bursa
Turkey	Haseki Egitim ve Arastirma Hastanesi	Istanbul
Turkey	Istanbul Florence Nightingale Hastanesi	Istanbul
Turkey	Medipol Mega Üniversite Hastanesi	Istanbul
Turkey	Saglik Bilimleri Üniversitesi Kanuni Sultan Süleyman Egitim ve Arastirma Hastanesi	Istanbul
Turkey	Saglik Bilimleri Üniversitesi Süleymaniye Kadin Dogum ve Çocuk Hastaliklari Egitim ve Arastirma Hastanesi	Istanbul
Turkey	Saglik Bilimleri Üniversitesi Ümraniye Egitim ve Arastirma Hastanesi	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Nutricia Research

Countries where clinical trial is conducted

Austria,  Poland,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool consistency measured by Amsterdam Stool Scale.	Will be reported in diaries completed by the parents.	15 months
Primary	Crying time	Will be reported in diaries completed by the parents.	15 months
Primary	Stool frequency	Will be reported in diaries completed by the parents.	15 months
Secondary	Eating behaviour	Baby Eating Behaviour Questionnaire	15 months
Secondary	Parental experience of child behaviour	PedsQL,	15 months
Secondary	Impact on family life	FamPedsQL	15 months