Feeding Intervention for Infants With Crying

This study has been terminated.
(The study has been terminated as a result of low enrollment.)
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01017991
First received: November 20, 2009
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

The purpose of the study is to assess if infants who have excessive crying and fussing have less of these symptoms when fed a formula containing a probiotic compared to those fed a standard infant formula.


Condition Intervention
Crying
Other: Milk based infant formula with probiotic
Other: Milk based infant formula

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of an Infant Formula With Probiotics on Signs and Symptoms of "Colic".

Resource links provided by NLM:


Further study details as provided by Nestlé:

Primary Outcome Measures:
  • daily total crying time [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Formula intake [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • Tolerance evaluated by stool, vomiting, spitting and flatulence frequencies [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: December 2009
Estimated Study Completion Date: March 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Infant formula with probiotic
Infant formula with probiotic for 0 to 12 months of age
Other: Milk based infant formula with probiotic
formula supplied as a powder to be constituted as commercially available formula ad libitum daily 28 days duration
Placebo Comparator: Standard infant formula
Infant formula for 0 to 12 months of age
Other: Milk based infant formula
supplied as a powder to be constituted as commercially available formula ad libitum daily 28 days

  Eligibility

Ages Eligible for Study:   up to 4 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • full term infants greater than or equal to 37 wks gestation
  • 3 weeks to less than or equal to 4 months of age upon enrollment
  • experiencing ongoing crying and fussy episodes of a minimum of 3 hours of crying /day for 3 days in a week for at least one week prior to enrollment
  • otherwise healthy as reported by parent/caregiver
  • is under the care of a pediatrician or other qualified healthcare professional and has had at least one postnatal visit
  • taking no more than one feeding of breast milk per day
  • having not initiated weaning foods or beverages other than infant formula or breast milk
  • study explained and written information provided with Parent/caregiver demonstrating understanding of the given information
  • informed consent signed(parent/legal representative)

Exclusion Criteria:

  • Chromosomal or major congenital anomalies
  • known cow's milk allergy
  • receiving any type of therapeutic formula (including extensively hydrolyzed formula or free amino acid formula)
  • receiving an antibiotic or probiotic in the week prior to enrollment
  • complicated reflux, defined by reflux combined with inadequate growth and/or respiratory complications
  • infant's family, who in the investigator's assessment, cannot be expected to comply with the protocol
  • infant currently participating in another conflicting clinical study
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01017991

Locations
United States, Arkansas
Children's Investigational Research Program, LLC
Bentonville, Arkansas, United States, 72712
United States, California
University of California, San Francisco
San Francisco, California, United States, 94118
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 2007
United States, Florida
Florida Institute for Clinical Research
Orlando, Florida, United States, 32822
United States, Indiana
Pedia Research, LLC
Newburgh, Indiana, United States, 47630
United States, Kentucky
Pedia Research
Owensboro, Kentucky, United States, 42301
United States, Nebraska
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States, 68504
United States, Texas
Cook Children's Medical Center
Ft. Worth, Texas, United States, 76104
Southwest Children's Research Associates, P.A.
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Michael D Cabana, MD,MPH University of California, San Francisco, USA
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01017991     History of Changes
Other Study ID Numbers: 09.03.INF
Study First Received: November 20, 2009
Last Updated: December 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Nestlé:
infants
formula
probiotic
crying

ClinicalTrials.gov processed this record on October 16, 2014