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Feeding Intervention for Infants With Crying

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: NCT01017991
Recruitment Status : Terminated (The study has been terminated as a result of low enrollment.)
First Posted : November 23, 2009
Last Update Posted : November 17, 2017
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Crying Other: Milk based infant formula with probiotic Other: Milk based infant formula Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of an Infant Formula With Probiotics on Signs and Symptoms of "Colic".
Study Start Date : December 2009
Actual Primary Completion Date : August 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. daily total crying time [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Formula intake [ Time Frame: 4 days ]
  2. Tolerance evaluated by stool, vomiting, spitting and flatulence frequencies [ Time Frame: 4 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:   3 Weeks to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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): NCT01017991

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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
Fort Worth, Texas, United States, 76104
Southwest Children's Research Associates, P.A.
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
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Principal Investigator: Michael D Cabana, MD,MPH University of California, San Francisco, USA
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Responsible Party: Nestlé Identifier: NCT01017991    
Other Study ID Numbers: 09.03.INF
First Posted: November 23, 2009    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Keywords provided by Nestlé: