Safety and Tolerance of a Partly Fermented Infant Formula With Prebiotic Oligosaccharides in Healthy Infants

Study Overview
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Brief Summary
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A randomised, controlled, double-blind, parallel group, multi-country study to investigate the safety and tolerance of a partly fermented infant formula containing prebiotic oligosaccharides in healthy term infants.

Official Title
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A Randomised, Controlled, Double-blind, Parallel Group, Multi-country Study to Investigate the Safety and Tolerance of a Partly Fermented Infant Formula Containing Prebiotic Oligosaccharides in Healthy Term Infants

Conditions
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Growth

Intervention / Treatment
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* Other: Infant formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, singleton, term infants Aged ≤14 days at randomisation/enrolment Birth weight within normal range for gestational age and sex Head circumference at birth within normal range for age and sex Maternal age ≥18 years at birth; Intervention arms: exclusively formula fed at randomisation (infants of mothers who autonomously chose not to breastfeed for any reason before their infant is ≤14 days of age, and who intend to exclusively formula feed until their infant is at least 17 weeks of age); OR Breastfed reference arm: exclusively breastfed at enrolment (infants of mothers who intend to exclusively breastfeed until their infant is at least 17 weeks of age); Written informed consent from parent(s) and/or legal guardian(s), who themselves are aged ≥18 years. Exclusion Criteria: Infants who require to be fed a special diet other than standard cow's milk based infant formula; Infants known or suspected to have cow's milk allergy, soy allergy and/or lactose intolerance; Infants known or suspected to have current or previous illnesses/conditions or interventions which could interfere with the study or its outcome parameters, as per the clinical judgement of the Investigator; Infants with known or suspected congenital diseases or malformations which could interfere with the study or its outcome parameters (including, but not limited to: GI malformations, congenital immunodeficiency), as per the clinical judgement of the Investigator; Infants with previous, current or intended participation in any other clinical study involving investigational or marketed products; Incapability of infants' parents/legally acceptable representatives to comply with study protocol or Investigator's uncertainty about the willingness or ability of the parent(s)/legally acceptable representative(s) to comply with the protocol requirements; Infants born from mothers with significant medical conditions during pregnancy that might interfere with the study or known to affect intra-uterine growth (e.g. placenta previa, pre-eclampsia, eclampsia, gestational diabetes requiring insulin or oral medication) as per Investigator's judgement. Criteria for lactating mothers of subjects in the breastfed reference arm: Lactating women who are currently participating or intend to participate in any other clinical study involving investigational products. Participation in purely observational studies is permitted; Lactating women known to suffer from hepatitis B or human immunodeficiency virus; Lactating women known to have any other significant medical condition(s) which might interfere with the study or its outcome parameters (breast abscess or mastitis which could interfere with lactation, or other clinically relevant infections, or consumption of medication/substances which could impact the infants' growth), as per the clinical judgement of the Investigator; Lactating women who intend to feed their infants with a combination of human milk and infant formula.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 14 Days

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Cows milk based infant formula containing fermented infant formula and prebiotic oligosaccharides | Other: Infant formula<br>* Infants are randomized to one of two infant formulas from <14 days of age to 17 weeks of age.<br>|
| Active Comparator: Control<br>Cows milk based infant formula containing prebiotic oligosaccharides (commercially available Aptamil ProNutra) | Other: Infant formula<br>* Infants are randomized to one of two infant formulas from <14 days of age to 17 weeks of age.<br>|
| No Intervention: Breastfed reference<br>Exclusively breastfed from birth to study completion | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain (infant formula comparison) | Equivalence of weight gain per day (g/d) from baseline until 17 weeks of age in subjects receiving the test product compared to infants receiving the control product | 17 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain (human milk comparison) | Equivalence of weight gain per day (g/d) from baseline until 17 weeks of age in subjects receiving the test product compared to infants receiving human milk | 17 weeks | 
| Recumbent Length gain | Equivalence of length gain per day (mm/d) from baseline until 17 weeks of age in subjects receiving the test product compared to infants receiving the control product or human milk | 17 weeks | 
| Head circumference gain | Equivalence of head circumference gain per day (mm/d) from baseline until 17 weeks of age in subjects receiving the test product compared to infants receiving the control product or human milk | 17 weeks | 
| Parent-reported GI Tolerance Parameters (daily diary) | Information on regurgitation and vomiting will be collected by a daily diary that is completed by the parents. | 17 weeks | 
| Parent-Reported Stool Characteristics (adapted Amsterdam Stool Scale) | Information on stool consistency (4-point scale) and stool frequency (number of stools per day) will be collected by a daily diary that is completed by the parents. Occurrence of diarrhea like-symptoms and constipation-like symptoms will be derived from the stool frequency and consistency data. | 17 weeks | 
| Incidence of treatment-related adverse events | Number of adverse events (by System/Organ Class and Preferred term according the MedDRA) as assessed and reported by the investigator. | 17 weeks | 
| Severity of treatment-related adverse events | Severity of adverse events (by System/Organ Class and Preferred term according the MedDRA) as assessed and reported by the investigator. | 17 weeks |