Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Infant Formula on Caregiver-perceived 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.
 
ClinicalTrials.gov Identifier: NCT03679234
Recruitment Status : Completed
First Posted : September 20, 2018
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Nestlé

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Understand the impact of switching to a commercially available infant formula on gastrointestinal symptoms

Condition or disease Intervention/treatment Phase
Healthy Infants Other: Routine infant formula Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Subjects and their parent/caregiver will be blinded to the intervention product. Care Providers at sites, Investigators, and Outcomes Assessors are unblinded to the intervention product.
Primary Purpose: Treatment
Official Title: Impact of Infant Formula on Caregiver-perceived Intolerance
Actual Study Start Date : September 24, 2018
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Intervention
Routine infant formula
 Other: Routine infant formula
Routine infant formula with probiotic


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Infant GI Symptom Burden [ Time Frame: 3 weeks ]
    Study personnel will administer questionnaire


Secondary Outcome Measures :
  1. Formula Intake [ Time Frame: 24 hours ]
    Caregivers will document on diary records

  2. Fussiness [ Time Frame: 24 hours ]
    Caregivers will document on diary records

  3. Formula Satisfaction Questionnaire [ Time Frame: 3 weeks ]
    Study personnel will administer questionnaire

  4. Adverse Events [ Time Frame: 24 hours and 3 weeks ]
    Assessed throughout study


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   up to 60 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy infant
  • Full-term (> 37 weeks gestation)
  • Birth weight > 2500 and < 4500 g
  • 14-60 days of age on enrollment
  • Singleton birth
  • Infant's mother has elected not to breastfeed prior to enrollment
  • Infant exclusively formula-fed for at least 5 days prior to enrollment
  • Caregiver perceives infant as very or extremely fussy according to perceived fussiness based on the previous 3 days
  • Caregiver wishes to switch infant's formula
  • Has not received solid foods
  • Having obtained his/her legal representative's informed consent

Exclusion Criteria:

  • Known or suspected cow-milk allergy
  • Currently receiving a specialty infant formula (e.g. thickened, extensively hydrolyzed, amino acid-based, metabolic)
  • Has switched formula more than two times since hospital discharge
  • Currently experiencing gastrointestinal or respiratory symptoms secondary to an ongoing infection or virus (e.g. gastrointestinal infection, upper respiratory infection, flu)
  • Congenital illness or malformation that may affect infant feeding and/or growth
  • Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment
  • Receiving probiotic supplements
  • Infant's family who in the Investigator's assessment cannot be expected to comply with treatment (feeding regimen).
  • Participation in another study that has not been approved as a concomitant study by Nestlé Nutrition.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03679234


Locations
Layout table for location information
United States, Connecticut
Norwich Pediatrics Group
Norwich, Connecticut, United States, 06360
United States, Kentucky
Qualmedica Research
Owensboro, Kentucky, United States, 42301
United States, Ohio
Ohio Pediatric Research Association
Dayton, Ohio, United States, 45414
United States, South Carolina
Coastal Pediatric Associates
Charleston, South Carolina, United States, 29414
United States, Tennessee
Midsouth Center for Clinical Research, LLC
Memphis, Tennessee, United States, 38116
United States, Texas
ClinPoint Trials
Waxahachie, Texas, United States, 75165
United States, Utah
Tanner Clinic
Layton, Utah, United States, 84041
Sponsors and Collaborators
Nestlé
Investigators
Layout table for investigator information
Study Director: Ryan Carvalho, MD Nestle Nutrition
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT03679234    
Other Study ID Numbers: 18.01.US.INF
First Posted: September 20, 2018    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No