NCT01681355

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 9, 2013

Status Verified

January 1, 2013

Enrollment Period

3 months

First QC Date

September 5, 2012

Last Update Submit

January 8, 2013

Conditions

Healthy Infants

Keywords

Healthy, term, Asian infantsInfant formula

Outcome Measures

Primary Outcomes (1)

  • Gastrointestinal tolerance

    Gastrointestinal tolerance is measured by stool consistency and gastrointestinal symptoms.

    up to Week 6

Other Outcomes (3)

  • Anthropometry

    Week 3, Week 6

  • Use of medication and nutritional supplements

    Week 1, Week 3, Week 6 and Week 8

  • Number, type and severity of (serious) adverse events

    Week 1, Week 3, Week 6 and Week 8

Study Arms (1)

Intervention group

EXPERIMENTAL

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

Interventions

Infant FormulaOTHER

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

Intervention group

Eligibility Criteria

AgeUp to 17 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Panembahan Senopati Distric Hospital

Bantul, DIY Yogyakarta, Indonesia

Location

Sakina Idaman Mothers and Children Hospital

Yogyakarta, DIY Yogyakarta, Indonesia

Location

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Location

Prince of Songkhla University Hospital

Hat Yai, Thailand

Location

Khon Kaen University Hospital

Khon Kaen, Thailand

Location

MeSH Terms

Interventions

Infant Formula

Intervention Hierarchy (Ancestors)

Milk SubstitutesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood, FormulatedFoods, SpecializedFoodInfant FoodFood and Beverages

Study Officials

  • Jan van der Mooren, PhD

    Danone Global Research & Innovation Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2012

First Posted

September 7, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 9, 2013

Record last verified: 2013-01

Locations

TH(3)ID(2)