Growth and Tolerance Trial on Infant Formula With HMO (Stardust)

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

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.

Study Overview

• Status: Terminated
• Conditions: Healthy Growth
• Intervention / Treatment: Other: Standard infant formula; Other: Infant formula supplemented with HMO

• Study Type: Interventional
• Enrollment (Actual): 265
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229-3026
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Breastfed group; Non-randomized breastfed reference group
Placebo Comparator: Control formula; Group receiving standard infant formula	Other: Standard infant formula; Standard infant formula
Active Comparator: Formula with HMO; Group receiving standard infant formula supplemented with HMO	Other: Infant formula supplemented with HMO; Infant formula supplemented with HMO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth	Infant growth measured as body weight gain per day	From enrollment until end of the 3 month-study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Infant weight (kg)	Monthly, from enrollment until end of the 3 month-study
Recumbent length	Infant length (cm and cm/day)	Monthly, from enrollment until end of the 3 month-study
Head circumference	Head circumference (cm and cm/day)	Monthly, from enrollment until end of the 3 month-study
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
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
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

Collaborators and Investigators

• Sponsor: FrieslandCampina

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2019
• Primary Completion (Actual): January 26, 2023
• Study Completion (Actual): January 26, 2023

Study Registration Dates

• First Submitted: August 21, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (Actual): August 26, 2019

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: growth; HMO; infant formula; human milk oligosaccharide
• Other Study ID Numbers: Stardust

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No