Feeding Intervention for Infants With Crying

Stopped early · Not applicable

Conditions studied: Crying

In brief

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.

Key facts

Study ID

NCT01017991

Run by

Société des Produits Nestlé (SPN)

People needed

65

Starts

2009-12-01

Expected to finish

2013-03-01

Last updated by the study team

2017-11-17

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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