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Use of a Probiotic Supplement to Prevent Asthma in Infants

NCT00113659 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2024-06-11

No results posted yet for this study

Summary

The goal of the study is to understand the mechanisms of how antigen presentation affects the developing immune system and subsequently affects susceptibility to, or protects against, asthma development. This randomized controlled study will test the effectiveness of daily supplementation of Lactobacillus GG for the first 6 months of life on the early immunological development of asthma.

Conditions

Interventions

DIETARY_SUPPLEMENT

Probiotic

Daily dose of ten to the tenth colony-forming units of Lactobacillus GG and 225 mg of inulin for the first 6 months of life.

DIETARY_SUPPLEMENT

Placebo

Daily dose of placebo supplement containing 325mg inulin for the first 6 month of life.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Michael D. Cabana, MD, MPH · Albert Einstein College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
4 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2014-05-31
Completion
2014-05-31

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 NCT00113659 on ClinicalTrials.gov