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Study in Unsettled Infants Experiencing Feeding Intolerance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02021058
Recruitment Status : Completed
First Posted : December 27, 2013
Last Update Posted : January 31, 2017
Information provided by (Responsible Party):

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Feeding Disorder Other: Experimental Formula Other: Standard control formula Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 259 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of an Experimental Infant Formula in Unsettled Infants Experiencing Feeding Intolerance
Actual Study Start Date : December 12, 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : August 23, 2016

Arm Intervention/treatment
Experimental: Experimental Formula
Experimental Formula
Other: Experimental Formula
Experimental formula

Standard Formula
Standard Control formula
Other: Standard control formula
Standard Infant formula

Primary Outcome Measures :
  1. Changes from baseline to 14 days in fuss-cry behavior [ Time Frame: from baseline to 14 days ]
    fuss-cry behavior per 24 hours

Secondary Outcome Measures :
  1. Change from baseline to 14 days in GI symptoms [ Time Frame: from baseline to 14 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 90 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02021058

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Hong Kong
The Chinese University of Hong Kong
Shatin, New Territories, Hong Kong
Asian Hospital and Medical Center
Filinvest Corporate City, Alabang, Muntinlupa City, Philippines, 1780
Chang Gung Memorial Hospital - Linkou
Hsiang, Taoyan Hsien, Taiwan
Mackay Memorial Hospital - Tamsui
New Taipei City, Taiwan
Mackay Memorial Hospital - Taipei
Taipei City, Taiwan
King Chulalongkorn Memorial Hospital - Faculty of Medicine, Chulalongkorn University
Pratumwan, Bangkok, Thailand, 10330
Sponsors and Collaborators
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Principal Investigator: Associate Professor Boosba Vivatvakin, MD Pediatric Department, Faculty of Medicine, Chulalongkorn University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Nestlé Identifier: NCT02021058    
Other Study ID Numbers: 13.10.INF
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Feeding and Eating Disorders
Mental Disorders