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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
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of California, Davis

Study Description
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Brief Summary:
The purpose of this study is to see whether dietary supplements can change the germs in the intestines of premature infants to be more like those of healthy breast fed term babies.

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

Detailed Description:
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). In the initial phase of this trial, 30 premature infants will be randomly assigned to receive increasing doses of one of four dietary supplements: Permeate (a pasteurized human milk concentrate containing human milk oligosaccharides processed by Prolacta), GOS (galacto-oligosaccharides manufactured by Friesland foods), Bifidobacterium infantis or Bifidobacterium animalis. Weekly stool specimens will be examined by PCR to determine content of bifidobacteria and total bacteria. This study is limited to formula fed infants in order to avoid the confounding effects of the human milk oligosaccharides in breast milk. An additional 12 human milk fed infants will be enrolled and will have their diet supplemented with ProlactPlus (a pasteurized human milk concentrate containing humna milk oligosaccharides) or powdered human milk fortifier for comparison
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Permeate
 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
GOS
 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
Bifidobacterium infantis
 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.
Other Names:
  • bifidobacteria
  • B. infantis
Active Comparator: 4
Bifidobacterium animalis
 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.
Other Names:
  • B. animalis
  • bifidobacteria


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Born in or transferred to UCDMC within the first two weeks of life. Birth weight less than 1500 grams. Gestational age less than 33 completed weeks. Exclusively formula fed.

Exclusion Criteria:

  • Gastrointestinal or cardiac anomalies.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Mark Underwood, MD University of California, Davis
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00810160    
Other Study ID Numbers: 243213
R01HD059127 ( U.S. NIH Grant/Contract )
HD059127-01 ( Other Identifier: UC Davis )
First Posted: December 17, 2008    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017
Keywords provided by University of California, Davis:
probiotic
prebiotic
oligosaccharides
GOS
 galacto oligosaccharides
Bifidobacterium infantis
Bifidobacterium animalis
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications