Gastrointestinal Tolerance Study of a New Infant Formula

Not Applicable

Completed

• Conditions: Healthy Infants
• Interventions: Other: Infant Formula

• Registration Number: NCT01681355
• Lead Sponsor: Danone Asia Pacific Holdings Pte, Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-05
• Study First Submitted QC: 2012-09-06
• Study First Posted: 2012-09-07
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-08
• Last Update Posted: 2013-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Gastrointestinal tolerance	up to Week 6	Gastrointestinal tolerance is measured by stool consistency and gastrointestinal symptoms.

Trial Locations

Locations (5)

Khon Kaen University Hospital; 🇹🇭 Khon Kaen, Thailand

Panembahan Senopati Distric Hospital; 🇮🇩 Bantul, DIY Yogyakarta, Indonesia

Sakina Idaman Mothers and Children Hospital; 🇮🇩 Yogyakarta, DIY Yogyakarta, Indonesia

King Chulalongkorn Memorial Hospital; 🇹🇭 Bangkok, Thailand

Prince of Songkhla University Hospital; 🇹🇭 Hat Yai, Thailand