Probiotic Use in Patients With Prior COPD Exacerbation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-12-31

Brief Summary

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The purpose of the study is to examine the hypothesis test that probiotics will reduce the frequency of exacerbation in patients with COPD.

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Detailed Description

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Conditions

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COPD Obstructive Lung Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Sugar Pill

1 pill orally daily

Group Type PLACEBO_COMPARATOR

Sugar pill

Intervention Type OTHER

placebo

Lactobacillus GG

1 pill (2 x 10x 9 CFU) daily orally

Group Type ACTIVE_COMPARATOR

Lactobacillus GG

Intervention Type DIETARY_SUPPLEMENT

probiotic supplement

Interventions

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Lactobacillus GG

probiotic supplement

Intervention Type DIETARY_SUPPLEMENT

Sugar pill

placebo

Intervention Type OTHER

Other Intervention Names

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Culturelle

Eligibility Criteria

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Inclusion Criteria

1. Patients admitted to OUMC or VAMC with a COPD exacerbation and pneumonia with underlying COPD will be eligible and screened.
2. Patients seen in VA Chest Medicine clinic, OU Physicians clinic and Pulmonary fellows clinic at PPOB who have had a COPD exacerbation within the last year.
3. Patients over age 18
4. Patients who have a pulmonary function test (PFT) showing COPD within 1 year of enrollment in the study or if the treating physician plans to obtain PFT as part of the patient's care plan.
5. Patients will be considered to have a diagnosis of COPD if they have a FEV1 of less than 80% of predicted and a FVC/FEV1 ratio of less than 0.70 (as defined by GOLD criteria).

Exclusion Criteria

1. Patients with less than one year of life expectancy from a concomitant diagnosis
2. Any GI motility disorders or previous bowel resection surgery (short gut syndrome)
3. Any patients with decreased immune function or on medication that may decrease immune function (other than low dose steroid or steroid taper).
4. Patients admitted within the last one year with a diagnosis of pancreatitis
5. Patients unable to give consent will not be included in the study.
6. Patients unable to sign consent
7. Patients already on azithromycin daily for COPD exacerbations
8. Patients under department of corrections custody.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No