Gastrointestinal Tolerance Study of a New Infant Formula

Healthy Infants Clinical Trial

— BOOGIE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01681355
• Other study ID #: BLU.1.C/A
• Status: Completed
• Phase: N/A
• First received: September 5, 2012
• Last updated: January 8, 2013
• Start date: September 2012
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Danone Asia Pacific Holdings Pte, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 17 Weeks

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Infants

Intervention

Other:
• Infant Formula
Standard cow's milk based infant formula with added prebiotic oligosaccharides, and a modified fat blend and protein composition

Locations

Country	Name	City	State
Indonesia	Panembahan Senopati Distric Hospital	Bantul	DIY Yogyakarta
Indonesia	Sakina Idaman Mothers and Children Hospital	Yogyakarta	DIY Yogyakarta
Thailand	King Chulalongkorn Memorial Hospital	Bangkok
Thailand	Prince of Songkhla University Hospital	Hat Yai
Thailand	Khon Kaen University Hospital	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Danone Asia Pacific Holdings Pte, Ltd.

Countries where clinical trial is conducted

Indonesia,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anthropometry		Week 3, Week 6	Yes
Other	Use of medication and nutritional supplements		Week 1, Week 3, Week 6 and Week 8	Yes
Other	Number, type and severity of (serious) adverse events		Week 1, Week 3, Week 6 and Week 8	Yes
Primary	Gastrointestinal tolerance	Gastrointestinal tolerance is measured by stool consistency and gastrointestinal symptoms.	up to Week 6	No