Clinical trial NCT01681355: Gastrointestinal Tolerance Study of a New Infant Formula
Official title: Open-label Study to Evaluate the Gastrointestinal Tolerance of a New Infant Formula in Healthy, Term, Asian Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Infants
Keywords: Healthy, term, Asian infants
Infant formula
Lead sponsor: Danone Asia Pacific Holdings Pte, Ltd.
Sponsor class: INDUSTRY
First posted: 2012-09-07
Enrollment: 50
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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


Eligibility 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.

Primary outcomes:
measure: Gastrointestinal tolerance
timeFrame: up to Week 6
Secondary outcomes:
Other outcomes:
measure: Anthropometry
timeFrame: Week 3, Week 6
measure: Use of medication and nutritional supplements
timeFrame: Week 1, Week 3, Week 6 and Week 8
measure: Number, type and severity of (serious) adverse events
timeFrame: Week 1, Week 3, Week 6 and Week 8
Locations:
city: Bantul
country: Indonesia
facility: Panembahan Senopati Distric Hospital
state: DIY Yogyakarta
city: Yogyakarta
country: Indonesia
facility: Sakina Idaman Mothers and Children Hospital
state: DIY Yogyakarta
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Hat Yai
country: Thailand
facility: Prince of Songkhla University Hospital
city: Khon Kaen
country: Thailand
facility: Khon Kaen University Hospital
Study officials:
affiliation: Danone Global Research & Innovation Center
name: Jan van der Mooren, PhD
role: STUDY_DIRECTOR
References: