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

University of California (UC) Davis

Status and phase: Completed; Phase 1

Conditions: Fecal Microflora in the Formula Fed Premature Infant

Treatments: Dietary Supplement: Bifidobacterium animalis; Dietary Supplement: Bifidobacterium infantis; Dietary Supplement: ProlactPlus; Dietary Supplement: GOS galacto-oligosaccharides

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00810160

HD059127-01 (Other Identifier)

243213

R01HD059127 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment: 59 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 4 patient groups

1

Active Comparator group

Description:

Permeate

Treatment:

Dietary Supplement: ProlactPlus

2

Active Comparator group

Description:

GOS

Treatment:

Dietary Supplement: GOS galacto-oligosaccharides

3

Active Comparator group

Description:

Bifidobacterium infantis

Treatment:

Dietary Supplement: Bifidobacterium infantis

4

Active Comparator group

Description:

Bifidobacterium animalis

Treatment:

Dietary Supplement: Bifidobacterium animalis