Growth and Tolerance Trial on Infant Formula With HMO

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy Growth

Intervention / Treatment
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* Other: Standard infant formula
* Other: Infant formula supplemented with HMO


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant formula, human milk oligosaccharide, HMO, growth