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Probiotic Use in Patients With Prior COPD Exacerbation

University of Oklahoma (OU) logo

University of Oklahoma (OU)

Status

Withdrawn

Conditions

Obstructive Lung Disease
COPD

Treatments

Dietary Supplement: Lactobacillus GG
Other: Sugar pill

Study type

Interventional

Funder types

Other

Identifiers

NCT02185092
4258
RSRCH032089 (Other Identifier)

Details and patient eligibility

About

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

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

0 participants in 2 patient groups, including a placebo group

Sugar Pill
Placebo Comparator group
Description:
1 pill orally daily
Treatment:
Other: Sugar pill
Lactobacillus GG
Active Comparator group
Description:
1 pill (2 x 10x 9 CFU) daily orally
Treatment:
Dietary Supplement: Lactobacillus GG

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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