Feeding Intervention for Infants With Crying

Effects of an Infant Formula With Probiotics on Signs and Symptoms of "Colic".

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.

Study Overview

• Status: Terminated
• Conditions: Crying
• Intervention / Treatment: Other: Milk based infant formula with probiotic; Other: Milk based infant formula

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Bentonville, Arkansas, United States, 72712
      • Children's Investigational Research Program, LLC
  • California
    • San Francisco, California, United States, 94118
      • University of California, San Francisco
  • District of Columbia
    • Washington, District of Columbia, United States, 2007
      • Georgetown University Medical Center
  • Florida
    • Orlando, Florida, United States, 32822
      • Florida Institute for Clinical Research
  • Indiana
    • Newburgh, Indiana, United States, 47630
      • Pedia Research, LLC
  • Kentucky
    • Owensboro, Kentucky, United States, 42301
      • Pedia Research
  • Nebraska
    • Lincoln, Nebraska, United States, 68504
      • Midwest Children's Health Research Institute
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Cook Children's Medical Center
    • San Antonio, Texas, United States, 78229
      • Southwest Children's Research Associates, P.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 weeks to 4 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
daily total crying time	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Formula intake	4 days
Tolerance evaluated by stool, vomiting, spitting and flatulence frequencies	4 days

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Principal Investigator: Michael D Cabana, MD,MPH, University of California, San Francisco, USA

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: November 20, 2009
• First Submitted That Met QC Criteria: November 20, 2009
• First Posted (Estimate): November 23, 2009

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 13, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: probiotic; infants; formula; crying
• Other Study ID Numbers: 09.03.INF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No