NCT02185092WithdrawnNot Applicable
Probiotic Use in Patients With Prior COPD Exacerbation
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- University of Oklahoma
- Locations
- 1
- Primary Endpoint
- COPD exacerbations
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Sugar Pill
Placebo Comparator
1 pill orally daily
Intervention: Sugar pill (Other)
Lactobacillus GG
Active Comparator
1 pill (2 x 10x 9 CFU) daily orally
Intervention: Lactobacillus GG (Dietary Supplement)
Outcomes
Primary Outcomes
COPD exacerbations
Time Frame: 1 year
The primary end point will be the number of COPD exacerbations.
Secondary Outcomes
- Antibiotic Use(1 year)
Investigators
Study Sites (1)
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