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Probiotics-Supplemented Feeding in Extremely Low Birth Weight Infants

NCT01164124 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2018-07-02

No results posted yet for this study

Summary

The overall purpose of this research is to test whether adding a supplement to the feeding of extremely low birth weight infant (infants weighing less than 2 pound 2 oz at birth) will help him/her achieve full feeding faster and achieve better weight gain.

Conditions

Interventions

DIETARY_SUPPLEMENT

Probiotic supplementation (Lactobacillus rhamnosus GG and Bifidobacterium infantis)

The probiotic regimen consisted of 500 million CFU of Lactobacillus rhamnosus GG (Culturelle, Amerifit Brand Inc.) and 500 million CFU of Bifidobacterium infantis (Align, Procter \& Gamble.Inc)

OTHER

Placebo

routine feedings

Sponsors & Collaborators

  • University of Vermont

    collaborator OTHER

  • St. Louis University

    collaborator OTHER

  • Cardinal Glennon Children's Hospital

    collaborator UNKNOWN

  • Saint John Hospital & Medical Center

    collaborator UNKNOWN

  • Vermont Oxford Network

    lead NETWORK

Principal Investigators

  • Mohamad Al-Hosni, MD · St. Louis University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
14 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-05-31
Completion
2009-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01164124 on ClinicalTrials.gov