Gastrointestinal Tolerance Study of a New Infant Formula

Study Overview
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Brief Summary
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This study is initiated to investigate the gastrointestinal tolerance of a new infant formula in healthy, term, Asian infants.

Official Title
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Open-label Study to Evaluate the Gastrointestinal Tolerance of a New Infant Formula in Healthy, Term, Asian Infants

Conditions
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Healthy Infants

Intervention / Treatment
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* Other: Infant Formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, well-nourished, term, Asian infants (gestational age ≥ 37 1/7 and ≤ 41 6/7 weeks) The mother had unequivocally decided not to exclusively breast-feed Formula fed for at least one week, receiving at least two formula feedings per day Birth weight appropriate for gestational age (AGA), 2500-4000g Written informed consent from parent(s) and/or legal guardian, aged ≥ 18 years. Exclusion Criteria: Age > 17 weeks Infants known to have current or previous illnesses/conditions or intervention which could interfere with the study (impacting tolerance and/or growth), such as gastrointestinal malformations, chronic diarrhoea, malabsorptive syndrome, malnutrition, congenital immunodeficiency, or major surgery, as per investigator's clinical judgement Infants who suffered from gastroenteritis or diarrhoea in the last 4 weeks preceding study start. Infants who used any medication or nutritional supplements (except for vitamin supplementation to complement breastfeeding) in the 4 weeks preceding study start. Infants who have medical conditions for which a special diet other than standard (non hydrolysed) cow's milk-based infant formula is required (such as cow's milk allergy, soy protein allergy, fish protein allergy, egg protein allergy, lactose intolerance, galactosemia). Infants with any history of or current participation in any other study involving investigational or marketed products. Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.

Ages Eligible for Study
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Maximum Age: 17 Weeks

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

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Healthy infants receiving standard cow's milk-based infant formula with added prebiotic oligosaccharides, and a modified fat blend and protein composition. | Other: Infant Formula<br>* Standard cow's milk based infant formula with added prebiotic oligosaccharides, and a modified fat blend and protein composition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal tolerance | Gastrointestinal tolerance is measured by stool consistency and gastrointestinal symptoms. | up to Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy, term, Asian infants, Infant formula