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Safety of VSL#3 in Adult Asthmatics

NCT00852124 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2023-04-20

Study results available
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Summary

We are proposing to test the safety of the probiotic, VSL#3, in a placebo controlled double blind safety study in 30 asthmatic adults. This adult safety trial was requested by the FDA IND review of a pediatric asthma protocol.

Adults with a doctor diagnosis of persistent asthma will take VSL#3 or placebo twice daily for 3 months. Data will be collected, including age, race, height, and weight, present medications, past medical history with emphasis on signs/symptoms of asthma.

On visits to the clinic we will evaluate

* Changes in lung function
* Intestinal permeability
* Intestinal bacteria
* Levels of inflammation in the blood
* Women will have repeat urine pregnancy testing at each clinic visit

Conditions

Interventions

BIOLOGICAL

VSL#3

VSL#3 2 times daily

BIOLOGICAL

VSL#3 or placebo

1 packet 2 x daily of placebo

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Alessio Fasano, M. D. · MBRC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2013-01-31
Completion
2013-01-31

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 NCT00852124 on ClinicalTrials.gov