Back to resultsProbiotic Use in Patients With Prior COPD Exacerbation
Primary Purpose
COPD, Obstructive Lung Disease
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lactobacillus GG
Sugar pill
Sponsored by
About this trial
This is an interventional treatment trial for COPD focused on measuring exacerbations, COPD, pneumonia, probiotic
Eligibility Criteria
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.
Sites / Locations
- OUHSC
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Sugar Pill
Lactobacillus GG
Arm Description
1 pill orally daily
1 pill (2 x 10x 9 CFU) daily orally
Outcomes
Primary Outcome Measures
COPD exacerbations
The primary end point will be the number of COPD exacerbations.
Secondary Outcome Measures
Antibiotic Use
Decreased oral or IV antibiotic use
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02185092
Brief Title
Probiotic Use in Patients With Prior COPD Exacerbation
Official Title
Probiotic Use in Patients With Prior COPD Exacerbation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Lost funding
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Obstructive Lung Disease
Keywords
exacerbations, COPD, pneumonia, probiotic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sugar Pill
Arm Type
Placebo Comparator
Arm Description
1 pill orally daily
Arm Title
Lactobacillus GG
Arm Type
Active Comparator
Arm Description
1 pill (2 x 10x 9 CFU) daily orally
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus GG
Other Intervention Name(s)
Culturelle
Intervention Description
probiotic supplement
Intervention Type
Other
Intervention Name(s)
Sugar pill
Intervention Description
placebo
Primary Outcome Measure Information:
Title
COPD exacerbations
Description
The primary end point will be the number of COPD exacerbations.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Antibiotic Use
Description
Decreased oral or IV antibiotic use
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Systemic Steroid Use
Description
Decreased systemic steroid use
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen S Allen, MD
Organizational Affiliation
OUHSC
Official's Role
Principal Investigator
Facility Information:
Facility Name
OUHSC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Probiotic Use in Patients With Prior COPD Exacerbation
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