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

September 5, 2012
January 8, 2013
September 2012
December 2012   (final data collection date for primary outcome measure)
Gastrointestinal tolerance [ Time Frame: up to Week 6 ] [ Designated as safety issue: No ]
Gastrointestinal tolerance is measured by stool consistency and gastrointestinal symptoms.
Same as current
Complete list of historical versions of study NCT01681355 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
  • 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 ]
Same as current
 
Gastrointestinal Tolerance Study of a New Infant Formula
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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Healthy Infants
Other: Infant Formula
Standard cow's milk based infant formula with added prebiotic oligosaccharides, and a modified fat blend and protein composition
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.
Intervention: Other: Infant Formula
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
up to 17 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
Indonesia,   Thailand
 
NCT01681355
BLU.1.C/A
No
Danone Asia Pacific Holdings Pte, Ltd.
Danone Asia Pacific Holdings Pte, Ltd.
Not Provided
Study Director: Jan van der Mooren, PhD Danone Research
Danone Asia Pacific Holdings Pte, Ltd.
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP