Growth of Infants Fed a New Term Infant Formula

Healthy Clinical Trial

Official title:

Growth of Infants Fed a New Term Infant Formula With a Prebiotic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03090360
• Other study ID #: 16.07.INF
• Status: Completed
• Phase: N/A
• Start date: February 21, 2017
• Est. completion date: May 21, 2019

Study information

• Verified date: July 2019
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the growth of healthy term infants fed an experimental infant formula with a prebiotic, a commercial control infant formula with a probiotic, but without a prebiotic and human breast milk

Description:

Multisite, double-blind, randomized, controlled clinical trial. The purpose of the study is to determine if infants fed a standard infant formula with a prebiotic have a weight gain in line with infants fed a standard starter infant formula without a prebiotic.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 349
• Est. completion date: May 21, 2019
• Est. primary completion date: April 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 14 Days

Eligibility

Inclusion Criteria:

1. Written informed consent signed and dated

2. Infants whose parent(s)/Legally Authorized Representative (LAR) have reached the legal age of majority in Belgium

3. Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol.

4. Infants whose parent(s)/LAR are able to be contacted directly by telephone throughout the study.

5. Infants whose parent(s)/LAR have a working freezer.

6. Healthy term, singleton infant at birth.

7. At enrollment visit, post-natal age = 14 days (date of birth = day 0).

8. At enrollment, birth weight = 2500g and = 4500g.

9. For formula-fed group, infant of parent(s)/LAR who have previously made the decision to formula feed their infant at the time of enrollment.

Exclusion Criteria:

1. Infants with conditions requiring infant feedings other than those specified in the protocol.

2. Infants receiving complementary foods or liquids.

3. Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results.

4. Infants who are presently receiving or have received prior to enrollment medications that could interfere with the interpretation of study results.

5. Infants or infants whose parent(s)/LAR who in the Investigator's assessment cannot be expected to comply with the protocol or with study procedures.

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Infant formula (CF)
Formula-fed infants will be randomly assigned to receive one of the study formulas (CF or EF) orally, ad libitum, each day from Study Day 1 until Study Day 180, for a treatment duration of approximately 180 days.
• Infant Formula (EF)
Formula-fed infants will be randomly assigned to receive one of the study formulas (CF or EF) orally, ad libitum, each day from Study Day 1 until Study Day 180, for a treatment duration of approximately 180 days.

Locations

Country	Name	City	State
Belgium	Algemeen Stedelijk Ziekenhuis Aalst	Aalst
Belgium	UZ Brussel	Brussel
Belgium	Kinderartsen Huis5	Hasselt
Belgium	Clinique Ste Elisabeth	Namur
Belgium	CHwapi	Tournai
Italy	Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda, Ospedale Maggiore Policlinico	Milano
Italy	AOUP "Paolo Giaccone"	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Countries where clinical trial is conducted

Belgium,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth	Growth (weight gain velocity)	120 days
Secondary	Growth	Other growth outcomes will be compared to the World Health Organization 2006 Growth Standards and by treatment group	Every month up to 6 months of age
Secondary	Stool patterns (3-day GI symptom and behavior diary - stool frequency and stool consistency)	Stool patterns (3-day GI symptom and behavior diary - stool frequency and stool consistency)	Every month up to 6 months of age
Secondary	GI tolerance (3-day GI symptom and behavior diary - including GI symptoms, GI-related behaviors, and milk intake)	GI tolerance (3-day GI symptom and behavior diary - including GI symptoms (frequency and amount of spitting-up/vomiting, and frequency of flatulence), GI-related behaviors (duration of crying and fussiness, sleeping, and the frequency of excessive crying episodes), and milk intake)	Every month up to 6 months of age
Secondary	Fecal microbiota composition and diversity (16S rRNA sequencing and qPCR)	Fecal microbiota composition, diversity, and abundance	Every month up to 4 months of age
Secondary	Fecal markers (pH, fecal organic acids, and protein markers of gut health)	Fecal markers (pH, fecal organic acids, and protein markers of gut health)	Every month up to 4 months of age
Secondary	Gene expression (infant exfoliated and microbial cell gene expression by shotgun sequencing)	Gene expression (infant exfoliated and microbial cell gene expression by shotgun sequencing)	Up to 3 months of age
Secondary	Adverse events / Morbidity	Adverse events / Morbidity	180 days