Completed

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

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What is being tested

Infant Formula

Other
Who is being recruted

+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorDanone Asia Pacific Holdings Pte, Ltd.
Last updated: January 9, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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

NCT01681355
Principal SponsorDanone Asia Pacific Holdings Pte, Ltd.
Last updated: January 9, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
Birth weight appropriate for gestational age (AGA), 2500-4000g
Formula fed for at least one week, receiving at least two formula feedings per day
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
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7 exclusion criteria prevent from participating
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 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 who suffered from gastroenteritis or diarrhoea in the last 4 weeks preceding study start
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Healthy infants receiving standard cow's milk-based infant formula with added prebiotic oligosaccharides, and a modified fat blend and protein composition.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Panembahan Senopati Distric Hospital

Bantul, IndonesiaOpen Panembahan Senopati Distric Hospital in Google Maps

Sakina Idaman Mothers and Children Hospital

Yogyakarta, Indonesia

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Prince of Songkhla University Hospital

Hat Yai, Thailand
Completed5 Study Centers