Growth and Tolerance Trial on Infant Formula With HMO

Healthy Growth Clinical Trial

— Stardust  

Official title:

Growth and Tolerance Trial in Healthy Infants on Infant Formula Supplemented With a Human Milk Oligosaccharide

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04066413
• Other study ID #: Stardust
• Status: Terminated
• Phase: N/A
• Start date: September 23, 2019
• Est. completion date: January 26, 2023

Study information

• Verified date: September 2023
• Source: FrieslandCampina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to compare growth of healthy infants fed an infant formula supplemented with a human milk oligosaccharide to that of infants on standard formula.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 265
• Est. completion date: January 26, 2023
• Est. primary completion date: January 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 1 Month

Eligibility

Inclusion Criteria:

• Gestational age = 37 weeks

• Birth weight = 2500 grams

• No recognized diseases (such as cardiac, pulmonary, gastrointestinal, renal or genetic diseases)

• Boys and girls

• Recruited < 1 month/age

• Being available for follow up until the age of 4 months

• Exclusive formula feeding or exclusive breast feeding at time of recruitment

Exclusion Criteria:

• Gestational age <37 weeks

• Birth weight <2500 grams

• Severe acquired or congenital diseases, mental or physical disorders

• Illness at screening/ inclusion

• Incapability of parents/caregivers to comply with the study protocol

• Received antibiotics within the first month of life

• Not tolerating standard cow's milk based infant formula

• Participation in another clinical trial

• Maternal illicit drug use during pregnancy or post-partum period

• Parent/caregiver does not have a cell phone to use for filling out questionnaires

Related Conditions & MeSH terms

• Healthy Growth

Intervention

Other:
• Standard infant formula
Standard infant formula
• Infant formula supplemented with HMO
Infant formula supplemented with HMO

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
FrieslandCampina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth	Infant growth measured as body weight gain per day	From enrollment until end of the 3 month-study
Secondary	Weight	Infant weight (kg)	Monthly, from enrollment until end of the 3 month-study
Secondary	Recumbent length	Infant length (cm and cm/day)	Monthly, from enrollment until end of the 3 month-study
Secondary	Head circumference	Head circumference (cm and cm/day)	Monthly, from enrollment until end of the 3 month-study
Secondary	Anthropometry z-scores	World Health Organization (WHO) growth standard calculated z-scores for weight, length, weight-for-length and head circumference	Monthly, from enrollment until end of the 3 month-study
Secondary	Formula tolerance	Parents are asked to keep a diary on formula intake 3 days prior to each monthly study visit	Monthly, from enrollment until end of the 3 month-study
Secondary	Gastro-intestinal comfort	Parents are asked to keep a diary 3 days prior to each monthly study visit including questions on gastro-intestinal symptoms (e.g. cramps, constipation, vomiting) and crying behavior	Monthly, from enrollment until end of the 3 month-study