Gastrointestinal Tolerance Study of a New Infant Formula (BOOGIE)

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Infants
• Intervention / Treatment: Other: Infant Formula

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DIY Yogyakarta
    • Bantul, DIY Yogyakarta, Indonesia
      • Panembahan Senopati Distric Hospital
    • Yogyakarta, DIY Yogyakarta, Indonesia
      • Sakina Idaman Mothers and Children Hospital
• Thailand
  • Bangkok, Thailand
    • King Chulalongkorn Memorial Hospital
  • Hat Yai, Thailand
    • Prince of Songkhla University Hospital
  • Khon Kaen, Thailand
    • Khon Kaen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; Standard cow's milk based infant formula with added prebiotic oligosaccharides, and a modified fat blend and protein composition

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
Anthropometry	Week 3, Week 6
Use of medication and nutritional supplements	Week 1, Week 3, Week 6 and Week 8
Number, type and severity of (serious) adverse events	Week 1, Week 3, Week 6 and Week 8

Collaborators and Investigators

• Sponsor: Danone Asia Pacific Holdings Pte, Ltd.
• Investigators: Study Director: Jan van der Mooren, PhD, Danone Research

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: September 5, 2012
• First Submitted That Met QC Criteria: September 6, 2012
• First Posted (Estimate): September 7, 2012

Study Record Updates

• Last Update Posted (Estimate): January 9, 2013
• Last Update Submitted That Met QC Criteria: January 8, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Infant formula; Healthy, term, Asian infants
• Other Study ID Numbers: BLU.1.C/A