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The Impact of Oligosaccharides and Bifidobacteria on the Intestinal Microflora of Premature Infants

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University of California, Davis
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00810160
First received: December 15, 2008
Last updated: December 15, 2014
Last verified: December 2014

December 15, 2008
December 15, 2014
June 2009
October 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00810160 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Impact of Oligosaccharides and Bifidobacteria on the Intestinal Microflora of Premature Infants
Phase 1A Study of Impact of Oligosaccharides and Bifidobacteria on the Intestinal Microflora of Premature Infants

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.

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Fecal Microflora in the Formula Fed Premature Infant
  • 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
  • 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
  • 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
  • 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
  • Active Comparator: 1
    Permeate
    Intervention: Dietary Supplement: ProlactPlus
  • Active Comparator: 2
    GOS
    Intervention: Dietary Supplement: GOS galacto-oligosaccharides
  • Active Comparator: 3
    Bifidobacterium infantis
    Intervention: Dietary Supplement: Bifidobacterium infantis
  • Active Comparator: 4
    Bifidobacterium animalis
    Intervention: Dietary Supplement: Bifidobacterium animalis
Underwood MA, Kalanetra KM, Bokulich NA, Lewis ZT, Mirmiran M, Tancredi DJ, Mills DA. A comparison of two probiotic strains of bifidobacteria in premature infants. J Pediatr. 2013 Dec;163(6):1585-1591.e9. doi: 10.1016/j.jpeds.2013.07.017. Epub 2013 Aug 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
April 2015
October 2014   (final data collection date for primary outcome measure)

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.
Both
Not Provided
Yes
Contact: Majid Mirmiran, MD, PhD 916-734-4790 majid.mirmiran@ucdmc.ucdavis.edu
Contact: Mark A Underwood, MD 916-762-7892 mark.underwood@ucdmc.ucdavis.edu
United States
 
NCT00810160
HD059127-01, R01HD059127
Yes
University of California, Davis
University of California, Davis
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Mark Underwood, MD University of California, Davis
University of California, Davis
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP