Probiotic Use in Patients With Prior COPD Exacerbation

Study Overview
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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.

Official Title
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Probiotic Use in Patients With Prior COPD Exacerbation

Conditions
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COPD, Obstructive Lung Disease

Intervention / Treatment
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* Dietary Supplement: Lactobacillus GG
* Other: Sugar pill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted to OUMC or VAMC with a COPD exacerbation and pneumonia with underlying COPD will be eligible and screened. 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. Patients over age 18 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. 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: Patients with less than one year of life expectancy from a concomitant diagnosis Any GI motility disorders or previous bowel resection surgery (short gut syndrome) Any patients with decreased immune function or on medication that may decrease immune function (other than low dose steroid or steroid taper). Patients admitted within the last one year with a diagnosis of pancreatitis Patients unable to give consent will not be included in the study. Patients unable to sign consent Patients already on azithromycin daily for COPD exacerbations Patients under department of corrections custody.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sugar Pill<br>1 pill orally daily | Other: Sugar pill<br>* placebo<br>|
| Active Comparator: Lactobacillus GG<br>1 pill (2 x 10x 9 CFU) daily orally | Dietary Supplement: Lactobacillus GG<br>* probiotic supplement<br>* Other names: Culturelle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COPD exacerbations | The primary end point will be the number of COPD exacerbations. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibiotic Use | Decreased oral or IV antibiotic use | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exacerbations, COPD, pneumonia, probiotic