Probiotic Use in Patients With Prior COPD Exacerbation

Not Applicable

Withdrawn

• Conditions: Obstructive Lung Disease; COPD
• Interventions: Other: Sugar pill; Dietary Supplement: Lactobacillus GG

• Registration Number: NCT02185092
• Lead Sponsor: University of Oklahoma

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-03
• Study First Submitted QC: 2014-07-03
• Study First Posted: 2014-07-09
• Study Start: 2014-10
• Primary Completion: 2016-10
• Study Completion: 2016-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-19
• Last Update Posted: 2017-05-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugar Pill	Sugar pill	1 pill orally daily
Lactobacillus GG	Lactobacillus GG	1 pill (2 x 10x 9 CFU) daily orally

Primary Outcome Measures

Name	Time	Method
COPD exacerbations	1 year	The primary end point will be the number of COPD exacerbations.

Secondary Outcome Measures

Name	Time	Method
Antibiotic Use	1 year	Decreased oral or IV antibiotic use

Trial Locations

Locations (1)

OUHSC; 🇺🇸 Oklahoma City, Oklahoma, United States