The Impact of Oligosaccharides and Bifidobacteria on the Intestinal Microflora of Premature Infants - Full Text View

Sponsored by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00810160

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- and fructo-oligosaccharides Dietary Supplement: Bifidobacterium infantis Dietary Supplement: Bifidobacterium bifidum	Phase I

MedlinePlus related topics: Dietary Supplements Premature Babies

Drug Information available for: Fructooligosaccharides

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	Phase 1A Study of Impact of Oligosaccharides and Bifidobacteria on the Intestinal Microflora of Premature Infants

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

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:	30
Study Start Date:	November 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator ProlactPlus	Dietary Supplement: ProlactPlus Group 1 infants will be fed a concentration of ProlactPlus 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.
2: Active Comparator GOS	Dietary Supplement: GOS galacto- and fructo-oligosaccharides Group 2 infants will have their formula supplemented with a combination of galacto- and fructo-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.
3: Active Comparator 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.
4: Active Comparator Bifidobacterium bifidum	Dietary Supplement: Bifidobacterium bifidum Group 4 infants will have their formula supplemented with B. bifidum 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.

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: ProlactPlus (a pasteurized human milk concentrate containing human milk oligosaccharides processed by Prolacta), GOS (galacto-oligosaccharides manufactured by Friesland foods), Bifidobacterium infantis or Bifidobacterium bifidus. 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 6 human milk fed infants will be enrolled and will have their diet supplemented with ProlactPlus 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810160

Contacts

Contact: Victoria Daher, BS, CCRC

916-703-5496

victoria.daher@ucdmc.ucdavis.edu

Locations

United States, California
UC Davis Medical Center	Recruiting
Sacramento, California, United States, 95817
Contact: Victoria Daher, BS, CCRC 916-703-5496 victoria.daher@ucdmc.ucdavis.edu
Principal Investigator: Mark Underwood, MD
Sub-Investigator: David Mills, Ph.D.

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Principal Investigator:

Mark Underwood, MD

University of California, Davis

More Information

Responsible Party:	UCD Health System ( Mark Underwood, MD )
Study ID Numbers:	HD059127-01
Study First Received:	December 15, 2008
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00810160
Health Authority:	United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

probiotic
probiotic
oligosaccharides
GOS

galacto oligosaccharides
fructo oligosaccharides
Bifidobacterium infantis
Bifidobacterium bifidus

ClinicalTrials.gov processed this record on January 14, 2009