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

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
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- Gastrointestinal tolerance [ Time Frame: up to Week 6 ]Gastrointestinal tolerance is measured by stool consistency and gastrointestinal symptoms.
- Anthropometry [ Time Frame: Week 3, Week 6 ]
- Use of medication and nutritional supplements [ Time Frame: Week 1, Week 3, Week 6 and Week 8 ]
- Number, type and severity of (serious) adverse events [ Time Frame: Week 1, Week 3, Week 6 and Week 8 ]

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Ages Eligible for Study: | up to 17 Weeks (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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
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 |
Study Director: | Jan van der Mooren, PhD | Danone Research |
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 |