Gastrointestinal Tolerance Study of a New Infant Formula (BOOGIE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Danone Asia Pacific Holdings Pte, Ltd.
ClinicalTrials.gov Identifier:
NCT01681355
First received: September 5, 2012
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention
Healthy Infants
Other: Infant Formula

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Open-label Study to Evaluate the Gastrointestinal Tolerance of a New Infant Formula in Healthy, Term, Asian Infants

Resource links provided by NLM:


Further study details as provided by Danone Asia Pacific Holdings Pte, Ltd.:

Primary Outcome Measures:
  • Gastrointestinal tolerance [ Time Frame: up to Week 6 ] [ Designated as safety issue: No ]
    Gastrointestinal tolerance is measured by stool consistency and gastrointestinal symptoms.


Other Outcome Measures:
  • Anthropometry [ Time Frame: Week 3, Week 6 ] [ Designated as safety issue: Yes ]
  • Use of medication and nutritional supplements [ Time Frame: Week 1, Week 3, Week 6 and Week 8 ] [ Designated as safety issue: Yes ]
  • Number, type and severity of (serious) adverse events [ Time Frame: Week 1, Week 3, Week 6 and Week 8 ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: September 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 17 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681355

Locations
Indonesia
Panembahan Senopati Distric Hospital
Bantul, DIY Yogyakarta, Indonesia
Sakina Idaman Mothers and Children Hospital
Yogyakarta, DIY Yogyakarta, Indonesia
Thailand
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
Prince of Songkhla University Hospital
Hat Yai, Thailand
Khon Kaen University Hospital
Khon Kaen, Thailand
Sponsors and Collaborators
Danone Asia Pacific Holdings Pte, Ltd.
Investigators
Study Director: Jan van der Mooren, PhD Danone Research
  More Information

No publications provided

Responsible Party: Danone Asia Pacific Holdings Pte, Ltd.
ClinicalTrials.gov Identifier: NCT01681355     History of Changes
Other Study ID Numbers: BLU.1.C/A
Study First Received: September 5, 2012
Last Updated: January 8, 2013
Health Authority: Thailand: Ministry of Public Health

Keywords provided by Danone Asia Pacific Holdings Pte, Ltd.:
Healthy, term, Asian infants
Infant formula

ClinicalTrials.gov processed this record on July 22, 2014