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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01017991
Other study ID # 09.03.INF
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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