Gastrointestinal Tolerance Study of a New Infant Formula

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2012-12-31

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.

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Detailed Description

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Conditions

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Healthy Infants

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Intervention group

Healthy infants receiving standard cow's milk-based infant formula with added prebiotic oligosaccharides, and a modified fat blend and protein composition.

Group Type EXPERIMENTAL

Infant Formula

Intervention Type OTHER

Standard cow's milk based infant formula with added prebiotic oligosaccharides, and a modified fat blend and protein composition

Interventions

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Infant Formula

Standard cow's milk based infant formula with added prebiotic oligosaccharides, and a modified fat blend and protein composition

Intervention Type OTHER

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.

Maximum Eligible Age

17 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes