Feeding Intervention for Infants With Crying
This study has been terminated.
(The study has been terminated as a result of low enrollment.)
Sponsor:
Nestlé
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01017991
First received: November 20, 2009
Last updated: December 19, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Crying |
Other: Milk based infant formula with probiotic Other: Milk based infant formula |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Effects of an Infant Formula With Probiotics on Signs and Symptoms of "Colic". |
Resource links provided by NLM:
Further study details as provided by Nestlé:
Primary Outcome Measures:
- daily total crying time [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Formula intake [ Time Frame: 4 days ] [ Designated as safety issue: No ]
- Tolerance evaluated by stool, vomiting, spitting and flatulence frequencies [ Time Frame: 4 days ] [ Designated as safety issue: No ]
| Enrollment: | 65 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | March 2013 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Infant formula with probiotic
Infant formula with probiotic for 0 to 12 months of age
|
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
|
|
Placebo Comparator: Standard infant formula
Infant formula for 0 to 12 months of age
|
Other: Milk based infant formula
supplied as a powder to be constituted as commercially available formula ad libitum daily 28 days
|
Eligibility| Ages Eligible for Study: | up to 4 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01017991
Locations
| United States, Arkansas | |
| Children's Investigational Research Program, LLC | |
| Bentonville, Arkansas, United States, 72712 | |
| United States, California | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94118 | |
| United States, District of Columbia | |
| Georgetown University Medical Center | |
| Washington, District of Columbia, United States, 2007 | |
| United States, Florida | |
| Florida Institute for Clinical Research | |
| Orlando, Florida, United States, 32822 | |
| United States, Indiana | |
| Pedia Research, LLC | |
| Newburgh, Indiana, United States, 47630 | |
| United States, Kentucky | |
| Pedia Research | |
| Owensboro, Kentucky, United States, 42301 | |
| United States, Nebraska | |
| Midwest Children's Health Research Institute | |
| Lincoln, Nebraska, United States, 68504 | |
| United States, Texas | |
| Cook Children's Medical Center | |
| Ft. Worth, Texas, United States, 76104 | |
| Southwest Children's Research Associates, P.A. | |
| San Antonio, Texas, United States, 78229 | |
Sponsors and Collaborators
Nestlé
Investigators
| Principal Investigator: | Michael D Cabana, MD,MPH | University of California, San Francisco, USA |
More Information
No publications provided
| Responsible Party: | Nestlé |
| ClinicalTrials.gov Identifier: | NCT01017991 History of Changes |
| Other Study ID Numbers: | 09.03.INF |
| Study First Received: | November 20, 2009 |
| Last Updated: | December 19, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Nestlé:
|
infants formula probiotic crying |
ClinicalTrials.gov processed this record on May 23, 2013