Feeding Intervention for Infants With Crying

Not Applicable

Terminated

• Conditions: Crying
• Interventions: Other: Milk based infant formula with probiotic; Other: Milk based infant formula

• Registration Number: NCT01017991
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-20
• Study First Submitted QC: 2009-11-20
• Study First Posted: 2009-11-23
• Study Start: 2009-12
• Primary Completion: 2012-08
• Study Completion: 2013-03
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-13
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infant formula with probiotic	Milk based infant formula with probiotic	Infant formula with probiotic for 0 to 12 months of age
Standard infant formula	Milk based infant formula	Infant formula for 0 to 12 months of age

Primary Outcome Measures

Name	Time	Method
daily total crying time	28 days

Secondary Outcome Measures

Name	Time	Method
Formula intake	4 days
Tolerance evaluated by stool, vomiting, spitting and flatulence frequencies	4 days

Trial Locations

Locations (9)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Midwest Children's Health Research Institute; 🇺🇸 Lincoln, Nebraska, United States

Florida Institute for Clinical Research; 🇺🇸 Orlando, Florida, United States

Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States

Cook Children's Medical Center; 🇺🇸 Fort Worth, Texas, United States

Pedia Research; 🇺🇸 Owensboro, Kentucky, United States

Pedia Research, LLC; 🇺🇸 Newburgh, Indiana, United States

Southwest Children's Research Associates, P.A.; 🇺🇸 San Antonio, Texas, United States

Children's Investigational Research Program, LLC; 🇺🇸 Bentonville, Arkansas, United States