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Gastrointestinal Tolerance Study of a New Infant Formula (BOOGIE)

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ClinicalTrials.gov Identifier: NCT01681355
Recruitment Status : Completed
First Posted : September 7, 2012
Last Update Posted : January 9, 2013
Sponsor:
Information provided by (Responsible Party):
Danone Asia Pacific Holdings Pte, Ltd.

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study is initiated to investigate the gastrointestinal tolerance of a new infant formula in healthy, term, Asian infants.

Condition or disease Intervention/treatment Phase
Healthy Infants Other: Infant Formula Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Open-label Study to Evaluate the Gastrointestinal Tolerance of a New Infant Formula in Healthy, Term, Asian Infants
Study Start Date : September 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

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U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Primary Outcome Measures :
  1. Gastrointestinal tolerance [ Time Frame: up to Week 6 ]
    Gastrointestinal tolerance is measured by stool consistency and gastrointestinal symptoms.


Other Outcome Measures:
  1. Anthropometry [ Time Frame: Week 3, Week 6 ]
  2. Use of medication and nutritional supplements [ Time Frame: Week 1, Week 3, Week 6 and Week 8 ]
  3. Number, type and severity of (serious) adverse events [ Time Frame: Week 1, Week 3, Week 6 and Week 8 ]

Eligibility Criteria
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Ages Eligible for Study:   up to 17 Weeks   (Child)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Danone Asia Pacific Holdings Pte, Ltd.
ClinicalTrials.gov Identifier: NCT01681355     History of Changes
Other Study ID Numbers: BLU.1.C/A
First Posted: September 7, 2012    Key Record Dates
Last Update Posted: January 9, 2013
Last Verified: January 2013

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