Study in Unsettled Infants Experiencing Feeding Intolerance

Nestlé

Status

Completed

Conditions

Feeding Disorder

Treatments

Other: Experimental Formula

Other: Standard control formula

Study type

Interventional

Funder types

Industry

Identifiers

NCT02021058

13.10.INF

Details and patient eligibility

About

Multinational, multicenter, clinical trial. To evaluate the effect of an experimental formula on GI symptoms and associated behaviors in unsettled infants with parent-reported feeding intolerance

Full 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.

Enrollment

259 patients

Sex

All

Ages

30 to 90 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Infants who are consuming any amount of supplemental human milk
Infants who are consuming weaning foods or beverages other than infant formula
Infants with known cow's milk allergy or family history of siblings with documented cow's milk protein intolerance/allergy
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