Feeding Intervention for Infants With Crying

Crying Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01017991
• Other study ID #: 09.03.INF
• Status: Terminated
• Phase: N/A
• First received: November 20, 2009
• Last updated: November 13, 2017
• Start date: December 2009
• Est. completion date: March 2013

Study information

• Verified date: November 2017
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 65
• Est. completion date: March 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 4 Months

Eligibility

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

Related Conditions & MeSH terms

• Crying

Intervention

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
• Milk based infant formula
supplied as a powder to be constituted as commercially available formula ad libitum daily 28 days

Locations

Country	Name	City	State
United States	Children's Investigational Research Program, LLC	Bentonville	Arkansas
United States	Cook Children's Medical Center	Fort Worth	Texas
United States	Midwest Children's Health Research Institute	Lincoln	Nebraska
United States	Pedia Research, LLC	Newburgh	Indiana
United States	Florida Institute for Clinical Research	Orlando	Florida
United States	Pedia Research	Owensboro	Kentucky
United States	Southwest Children's Research Associates, P.A.	San Antonio	Texas
United States	University of California, San Francisco	San Francisco	California
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	daily total crying time		28 days
Secondary	Formula intake		4 days
Secondary	Tolerance evaluated by stool, vomiting, spitting and flatulence frequencies		4 days