The Impact of Oligosaccharides and Bifidobacteria on the Intestinal Microflora of Premature Infants
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|ClinicalTrials.gov Identifier: NCT00810160|
Recruitment Status : Completed
First Posted : December 17, 2008
Last Update Posted : July 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Fecal Microflora in the Formula Fed Premature Infant||Dietary Supplement: ProlactPlus Dietary Supplement: GOS galacto-oligosaccharides Dietary Supplement: Bifidobacterium infantis Dietary Supplement: Bifidobacterium animalis||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1A Study of Impact of Oligosaccharides and Bifidobacteria on the Intestinal Microflora of Premature Infants|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
Active Comparator: 1
Dietary Supplement: ProlactPlus
Group 1 infants will be fed a concentration of Permeate mixed with formula. The ProlactPlus will be increased each week as follows: week 1 95:5 (formula:ProlactPlus), week 2 90:10, week 3 85:15, week 4 80:20, and week 5 75:25. Caloric content is roughly as follows: week 1 21 cal/oz, week 2 22 cal/oz, week 3 23 cal/oz, week 4 24 cal/oz, and week 5 25 cal/oz.
Other Name: human milk oligosaccharides
Active Comparator: 2
Dietary Supplement: GOS galacto-oligosaccharides
Group 2 infants will have their formula supplemented with galacto-oligosaccharides (GOS) for each feeding as follows: week 1 0.25 g/dL, week 2 0.5 g/dL, week 3 1.0 g/dL, week 4 1.5 g/dL, and week 5 2.0 g/dL.
Other Name: galacto-oligosaccharides
Active Comparator: 3
Dietary Supplement: Bifidobacterium infantis
Group 3 infants will have their formula supplemented with B. infantis twice daily increasing the dose each week as follows: week 1 5x107, week 2 1.5x108, week 3 4.5x108, week 4 1.4x109, and week 5 4.2x109.
Active Comparator: 4
Dietary Supplement: Bifidobacterium animalis
Group 4 infants will have their formula supplemented with B. animalis twice daily increasing the dose each week as follows: week 1 5x107, week 2 1.5x108, week 3 4.5x108, week 4 1.4x109, and week 5 4.2x109.
- To determine the optimum dose and optimum dietary supplement to promote a fecal microflora in the formula fed premature infant that is similar to that of the term breast fed infant (a predominance of bifidobacteria). [ Time Frame: six weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00810160
|United States, California|
|UC Davis Medical Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Mark Underwood, MD||University of California, Davis|