Clinical trial NCT01017991: Feeding Intervention for Infants With Crying
Official title: Effects of an Infant Formula With Probiotics on Signs and Symptoms of "Colic".
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Crying
Keywords: infants
formula
probiotic
crying
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2009-11-23
Enrollment: 65
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: daily total crying time
timeFrame: 28 days
Secondary outcomes:
measure: Formula intake
timeFrame: 4 days
measure: Tolerance evaluated by stool, vomiting, spitting and flatulence frequencies
timeFrame: 4 days
Other outcomes:
Locations:
city: Bentonville
country: United States
facility: Children's Investigational Research Program, LLC
state: Arkansas
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Orlando
country: United States
facility: Florida Institute for Clinical Research
state: Florida
city: Newburgh
country: United States
facility: Pedia Research, LLC
state: Indiana
city: Owensboro
country: United States
facility: Pedia Research
state: Kentucky
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute
state: Nebraska
city: Fort Worth
country: United States
facility: Cook Children's Medical Center
state: Texas
city: San Antonio
country: United States
facility: Southwest Children's Research Associates, P.A.
state: Texas
Study officials:
affiliation: University of California, San Francisco, USA
name: Michael D Cabana, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References: