NCT00282113

Brief Summary

The purpose of this study is to see how oral preparations containing both probiotics and prebiotics impact the growth, bacterial colonization of the intestines, and fecal short chain fatty acid content in premature infants. Our hypothesis is that short term growth will be improved, the stool will have more healthy bacteria, and the fecal short chain fatty acid content will increase in the babies who receive the probiotic/prebiotic combinations compared to control groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2004

Typical duration for not_applicable

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

Study Start

First participant enrolled

October 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

January 28, 2010

Completed
Last Updated

January 28, 2010

Status Verified

December 1, 2009

Enrollment Period

1.8 years

First QC Date

January 23, 2006

Results QC Date

November 19, 2009

Last Update Submit

December 31, 2009

Conditions

Premature InfantsStool Bacterial CompositionGrowth

Keywords

ProbioticPrebioticNECPremature infantscommensal flora

Outcome Measures

Primary Outcomes (1)

  • Weight Gain

    Weight at five weeks minus birth weight

    5 weeks

Secondary Outcomes (2)

  • Stool Colonization With Bifidobacteria

    4 weeks

  • Stool Short Chain Butyric Acid Content

    4 weeks

Study Arms (3)

ProBioPlus

ACTIVE COMPARATOR
Dietary Supplement: ProBioPlus

Culturelle

ACTIVE COMPARATOR
Dietary Supplement: Culturelle

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

ProBioPlusDIETARY_SUPPLEMENT

ProBioPlus is advertised as containing Lactobacillus acidophilus, Bifidobacterium longum, Bifidobacterium infantis, and Bifidobacterium bifidum plus inulin. The dose given was 5 x 10e8 twice daily.

ProBioPlus
CulturelleDIETARY_SUPPLEMENT

Culturelle is advertised as containing Lactobacillus rhamnosus GG. The dose was 5 x 10e8 twice daily.

Culturelle
PlaceboOTHER

A dilute preparation of pregestimil powder formulated to have a similar appearance to the probiotic products

Placebo

Eligibility Criteria

AgeUp to 7 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • less than 35 weeks gestation, birth weight 750-2000 grams
  • born in or transferred to University of California Davis Medical Center within first week of life
  • less than eight days of age at the time of enrollment

You may not qualify if:

  • Severe intestinal or cardiac congenital anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Related Publications (1)

  • Underwood MA, Salzman NH, Bennett SH, Barman M, Mills DA, Marcobal A, Tancredi DJ, Bevins CL, Sherman MP. A randomized placebo-controlled comparison of 2 prebiotic/probiotic combinations in preterm infants: impact on weight gain, intestinal microbiota, and fecal short-chain fatty acids. J Pediatr Gastroenterol Nutr. 2009 Feb;48(2):216-25. doi: 10.1097/MPG.0b013e31818de195.

    PMID: 19179885RESULT

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Limitations and Caveats

Smaller sample size than anticipated due to the number of infants enrolled who were discharged home prior to completing five weeks of treatment.

Results Point of Contact

Title
Mark A. Underwood MD
Organization
University of California Davis
mark.underwood@ucdmc.ucdavis.edu
916-734-5061

Study Officials

  • Michael P Sherman, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 23, 2006

First Posted

January 25, 2006

Study Start

October 1, 2004

Primary Completion

August 1, 2006

Study Completion

August 1, 2007

Last Updated

January 28, 2010

Results First Posted

January 28, 2010

Record last verified: 2009-12

Locations

US(1)