Probiotic Use in Patients With Prior COPD Exacerbation

COPD Clinical Trial

Official title:

Probiotic Use in Patients With Prior COPD Exacerbation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02185092
• Other study ID #: 4258
• Secondary ID: RSRCH032089
• Status: Withdrawn
• Phase: N/A
• First received: July 3, 2014
• Last updated: May 19, 2017
• Start date: October 2014
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to examine the hypothesis test that probiotics will reduce the frequency of exacerbation in patients with COPD.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Obstructive Lung Disease

Intervention

Dietary Supplement:
• Lactobacillus GG
probiotic supplement

Other:
• Sugar pill
placebo

Locations

Country	Name	City	State
United States	OUHSC	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Systemic Steroid Use	Decreased systemic steroid use	1 year
Primary	COPD exacerbations	The primary end point will be the number of COPD exacerbations.	1 year
Secondary	Antibiotic Use	Decreased oral or IV antibiotic use	1 year