NCT00810160

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 17, 2008

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

6.4 years

First QC Date

December 15, 2008

Last Update Submit

July 11, 2017

Conditions

Fecal Microflora in the Formula Fed Premature Infant

Keywords

probioticprebioticoligosaccharidesGOSgalacto oligosaccharidesBifidobacterium infantisBifidobacterium animalis

Outcome Measures

Primary Outcomes (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).

    six weeks

Study Arms (4)

1

ACTIVE COMPARATOR

Permeate

Dietary Supplement: ProlactPlus

2

ACTIVE COMPARATOR

GOS

Dietary Supplement: GOS galacto-oligosaccharides

3

ACTIVE COMPARATOR

Bifidobacterium infantis

Dietary Supplement: Bifidobacterium infantis

4

ACTIVE COMPARATOR

Bifidobacterium animalis

Dietary Supplement: Bifidobacterium animalis

Interventions

ProlactPlusDIETARY_SUPPLEMENT

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.

Also known as: human milk oligosaccharides
1
GOS galacto-oligosaccharidesDIETARY_SUPPLEMENT

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.

Also known as: galacto-oligosaccharides
2
Bifidobacterium infantisDIETARY_SUPPLEMENT

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.

Also known as: bifidobacteria, B. infantis
3
Bifidobacterium animalisDIETARY_SUPPLEMENT

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.

Also known as: B. animalis, bifidobacteria
4

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Gastrointestinal or cardiac anomalies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Related Publications (1)

  • 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.

    PMID: 23993139DERIVED

MeSH Terms

Interventions

bificin C6165, Bifidobacterium animalis

Study Officials

  • Mark Underwood, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2008

First Posted

December 17, 2008

Study Start

June 1, 2009

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

July 13, 2017

Record last verified: 2017-07

Locations

US(1)