COPD, Obstructive Lung Disease
Conditions
Keywords
exacerbations, COPD, pneumonia, probiotic
Brief summary
The purpose of the study is to examine the hypothesis test that probiotics will reduce the frequency of exacerbation in patients with COPD.
Interventions
DIETARY_SUPPLEMENTLactobacillus GG
probiotic supplement
OTHERSugar pill
placebo
Sponsors
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COPD exacerbations | 1 year | The primary end point will be the number of COPD exacerbations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibiotic Use | 1 year | Decreased oral or IV antibiotic use |
Other
| Measure | Time frame | Description |
|---|---|---|
| Systemic Steroid Use | 1 year | Decreased systemic steroid use |
Countries
United States
Outcome results
None listed