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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of California, Davis.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00810160
First received: December 15, 2008
Last updated: March 14, 2011
Last verified: March 2011
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase 1A Study of Impact of Oligosaccharides and Bifidobacteria on the Intestinal Microflora of Premature Infants

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 36
Study Start Date: June 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Genders Eligible for Study:   Both
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
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: NCT00810160

Contacts
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

Locations
United States, California
UC Davis Medical Center Recruiting
Sacramento, California, United States, 95817
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   
Principal Investigator: Mark Underwood, MD         
Sub-Investigator: David Mills, Ph.D.         
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Mark Underwood, MD University of California, Davis
  More Information

No publications provided by University of California, Davis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mark Underwood, MD, UCD Health System
ClinicalTrials.gov Identifier: NCT00810160     History of Changes
Other Study ID Numbers: HD059127-01, R01HD059127
Study First Received: December 15, 2008
Last Updated: March 14, 2011
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of California, Davis:
probiotic
prebiotic
oligosaccharides
GOS
galacto oligosaccharides
Bifidobacterium infantis
Bifidobacterium animalis

ClinicalTrials.gov processed this record on October 16, 2014