This trial is active, not recruiting.

Condition feeding disorder
Treatments experimental formula, standard control formula
Sponsor Nestlé
Start date December 2013
End date April 2016
Trial size 259 participants
Trial identifier NCT02021058, 13.10.INF


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Experimental Formula
experimental formula
Experimental formula
Standard Control formula
standard control formula
Standard Infant formula

Primary Outcomes

Changes from baseline to 14 days in fuss-cry behavior
time frame: from baseline to 14 days

Secondary Outcomes

Change from baseline to 14 days in GI symptoms
time frame: from baseline to 14 days

Eligibility Criteria

Male or female participants up to 90 days old.

Inclusion Criteria: 1. Full term infants, singleton, healthy at birth 2. Infants of parent(s)/LAR who have previously made the decision to exclusively formula feed their infant. 3. Infants exclusively consuming a standard formula for a minimum of 3 consecutive days prior to enrolment. 4. 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: 1. Infants who are consuming any amount of supplemental human milk 2. Infants who are consuming weaning foods or beverages other than infant formula 3. Infants with known cow's milk allergy or family history of siblings with documented cow's milk protein intolerance/allergy 4. Infants who have a medical condition or history that could cause or contribute to feeding intolerance 5. Infants who received any other investigational intervention or who have participated in another clinical trial prior to enrolment

Additional Information

Official title Effect of an Experimental Infant Formula in Unsettled Infants Experiencing Feeding Intolerance
Principal investigator Associate Professor Boosba Vivatvakin, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Nestlé.