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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: March 25, 2015
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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, 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 ]
Secondary Outcome Measures:
- Formula intake [ Time Frame: 4 days ]
- Tolerance evaluated by stool, vomiting, spitting and flatulence frequencies [ Time Frame: 4 days ]
| Enrollment: | 65 |
| Study Start Date: | December 2009 |
| 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 (Child) |
| Sexes Eligible for Study: | All |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01017991
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
| 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: | March 25, 2015 |
Keywords provided by Nestlé:
|
infants formula probiotic crying |
ClinicalTrials.gov processed this record on July 14, 2017