Recruitment

Recruitment Status
Completed
Estimated Enrollment
260

Inclusion Criterias

Full term infants, singleton, healthy at birth
Infants of parent(s)/LAR who have previously made the decision to exclusively formula feed their infant.
Infant's parent(s)/LAR are of legal age of consent and are willing and able to fulfil the requirements of the study protocol.
...
Full term infants, singleton, healthy at birth
Infants of parent(s)/LAR who have previously made the decision to exclusively formula feed their infant.
Infant's parent(s)/LAR are of legal age of consent and are willing and able to fulfil the requirements of the study protocol.
Infants exclusively consuming a standard formula for a minimum of 3 consecutive days prior to enrolment.

Exclusion Criterias

Infants who are consuming any amount of supplemental human milk
Infants who are consuming weaning foods or beverages other than infant formula
Infants who have a medical condition or history that could cause or contribute to feeding intolerance
...
Infants who are consuming any amount of supplemental human milk
Infants who are consuming weaning foods or beverages other than infant formula
Infants who have a medical condition or history that could cause or contribute to feeding intolerance
Infants who received any other investigational intervention or who have participated in another clinical trial prior to enrolment
Infants with known cow's milk allergy or family history of siblings with documented cow's milk protein intolerance/allergy

Summary

Conditions
Feeding Disorder
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Younger than 90 years
Gender
Both males and females

Description

The purpose of the present study is therefore to evaluate the effect of an experimental formula in an unsettled formula-fed infant population whose parents are considering switching formulas due to perceived feeding intolerance.

The purpose of the present study is therefore to evaluate the effect of an experimental formula in an unsettled formula-fed infant population whose parents are considering switching formulas due to perceived feeding intolerance.

Inclusion Criterias

Full term infants, singleton, healthy at birth
Infants of parent(s)/LAR who have previously made the decision to exclusively formula feed their infant.
Infant's parent(s)/LAR are of legal age of consent and are willing and able to fulfil the requirements of the study protocol.
...
Full term infants, singleton, healthy at birth
Infants of parent(s)/LAR who have previously made the decision to exclusively formula feed their infant.
Infant's parent(s)/LAR are of legal age of consent and are willing and able to fulfil the requirements of the study protocol.
Infants exclusively consuming a standard formula for a minimum of 3 consecutive days prior to enrolment.

Exclusion Criterias

Infants who are consuming any amount of supplemental human milk
Infants who are consuming weaning foods or beverages other than infant formula
Infants who have a medical condition or history that could cause or contribute to feeding intolerance
...
Infants who are consuming any amount of supplemental human milk
Infants who are consuming weaning foods or beverages other than infant formula
Infants who have a medical condition or history that could cause or contribute to feeding intolerance
Infants who received any other investigational intervention or who have participated in another clinical trial prior to enrolment
Infants with known cow's milk allergy or family history of siblings with documented cow's milk protein intolerance/allergy

Locations

Shatin, New Territories
Taipei City
Hsiang, Taoyan Hsien
New Taipei City
Filinvest Corporate City, Alabang, Muntinlupa City, 1780
...
Shatin, New Territories
Taipei City
Hsiang, Taoyan Hsien
New Taipei City
Filinvest Corporate City, Alabang, Muntinlupa City, 1780
Pratumwan, Bangkok, 10330

Tracking Information

NCT #
NCT02021058
Collaborators
Not Provided
Investigators
  • Principal Investigator: Associate Professor Boosba Vivatvakin, MD Pediatric Department, Faculty of Medicine, Chulalongkorn University
  • Associate Professor Boosba Vivatvakin, MD Pediatric Department, Faculty of Medicine, Chulalongkorn University