Growth and Tolerance Trial on Infant Formula With HMO

Not Applicable

Terminated

• Conditions: Healthy Growth
• Interventions: Other: Standard infant formula; Other: Infant formula supplemented with HMO

• Registration Number: NCT04066413
• Lead Sponsor: FrieslandCampina

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-21
• Study First Submitted QC: 2019-08-22
• Study First Posted: 2019-08-26
• Study Start: 2019-09-23
• Primary Completion: 2023-01-26
• Study Completion: 2023-01-26
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 265

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control formula	Standard infant formula	Group receiving standard infant formula
Formula with HMO	Infant formula supplemented with HMO	Group receiving standard infant formula supplemented with HMO

Primary Outcome Measures

Name	Time	Method
Growth	From enrollment until end of the 3 month-study	Infant growth measured as body weight gain per day

Secondary Outcome Measures

Name	Time	Method
Weight	Monthly, from enrollment until end of the 3 month-study	Infant weight (kg)
Head circumference	Monthly, from enrollment until end of the 3 month-study	Head circumference (cm and cm/day)
Recumbent length	Monthly, from enrollment until end of the 3 month-study	Infant length (cm and cm/day)
Anthropometry z-scores	Monthly, from enrollment until end of the 3 month-study	World Health Organization (WHO) growth standard calculated z-scores for weight, length, weight-for-length and head circumference
Formula tolerance	Monthly, from enrollment until end of the 3 month-study	Parents are asked to keep a diary on formula intake 3 days prior to each monthly study visit
Gastro-intestinal comfort	Monthly, from enrollment until end of the 3 month-study	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

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States