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Study in Unsettled Infants Experiencing Feeding Intolerance

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ClinicalTrials.gov Identifier: NCT02021058
Recruitment Status : Completed
First Posted : December 27, 2013
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Nestlé

Study Description
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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.
Study Design
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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
Arms and Interventions
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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


Outcome Measures
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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 ]

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

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02021058


Locations
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Hong Kong
The Chinese University of Hong Kong
Shatin, New Territories, Hong Kong
Philippines
Asian Hospital and Medical Center
Filinvest Corporate City, Alabang, Muntinlupa City, Philippines, 1780
Taiwan
Chang Gung Memorial Hospital - Linkou
Hsiang, Taoyan Hsien, Taiwan
Mackay Memorial Hospital - Tamsui
New Taipei City, Taiwan
Mackay Memorial Hospital - Taipei
Taipei City, Taiwan
Thailand
King Chulalongkorn Memorial Hospital - Faculty of Medicine, Chulalongkorn University
Pratumwan, Bangkok, Thailand, 10330
Sponsors and Collaborators
Nestlé
Investigators
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Principal Investigator: Associate Professor Boosba Vivatvakin, MD Pediatric Department, Faculty of Medicine, Chulalongkorn University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Nestlé
ClinicalTrials.gov 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