Probiotic Use in Patients With Prior COPD Exacerbation

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

Study Overview

• Status: Withdrawn
• Conditions: COPD; Obstructive Lung Disease
• Intervention / Treatment: Other: Sugar pill; Dietary supplement: Lactobacillus GG

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • OUHSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Sugar Pill; 1 pill orally daily	Other: Sugar pill; placebo
Active Comparator: Lactobacillus GG; 1 pill (2 x 10x 9 CFU) daily orally	Dietary supplement: Lactobacillus GG; probiotic supplement; Other Names: Culturelle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COPD exacerbations	The primary end point will be the number of COPD exacerbations.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibiotic Use	Decreased oral or IV antibiotic use	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systemic Steroid Use	Decreased systemic steroid use	1 year

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Karen S Allen, MD, OUHSC

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: July 3, 2014
• First Submitted That Met QC Criteria: July 3, 2014
• First Posted (Estimate): July 9, 2014

Study Record Updates

• Last Update Posted (Actual): May 23, 2017
• Last Update Submitted That Met QC Criteria: May 19, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: COPD; exacerbations; probiotic; pneumonia
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive
• Other Study ID Numbers: 4258; RSRCH032089 (Other Identifier: OUHSC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No