|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00282113 |
|
Date of registration:
|
23/01/2006 |
|
Primary sponsor: |
|
|
Public title:
|
Effects of Probiotic and Prebiotic Combinations on Premature Infants
|
|
Scientific title:
|
Efficacy of a Prebiotic and Probiotic Combination in Preterm Infants |
|
Date of first enrolment:
|
October 2004 |
|
Target sample size:
|
90 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00282113 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Michael P Sherman, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of California, Davis |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- less than 35 weeks gestation, birth weight 750-2000 grams
- born in or transferred to University of California Davis Medical Center within first
week of life
- less than eight days of age at the time of enrollment
Exclusion Criteria:
- Severe intestinal or cardiac congenital anomalies
Age minimum:
N/A
Age maximum:
7 Days
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Growth
|
|
Premature Infants
|
|
Stool Bacterial Composition
|
|
Intervention(s)
|
|
Dietary Supplement: Culturelle
|
|
Dietary Supplement: ProBioPlus
|
|
Other: Placebo
|
|
Primary Outcome(s)
|
|
Weight Gain
[Time Frame: 5 weeks]
|
|
Secondary Outcome(s)
|
|
Stool Colonization With Bifidobacteria
[Time Frame: 4 weeks]
|
|
Stool Short Chain Butyric Acid Content
[Time Frame: 4 weeks]
|
|
Secondary ID(s)
|
|
2004122333-1
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|