Probiotic Use in Patients With Prior COPD Exacerbation

NCT02185092 | Withdrawn DMC

• 2 other identifiers: 4258RSRCH032089
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Obstructive Lung Disease

Keywords

exacerbations; COPD; pneumonia; probiotic

Outcome Measures

Primary Outcomes (1)

• COPD exacerbations

  The primary end point will be the number of COPD exacerbations.

  1 year

Secondary Outcomes (1)

• Antibiotic Use

  1 year

Other Outcomes (1)

• Systemic Steroid Use

  1 year

Study Arms (2)

Sugar Pill

PLACEBO COMPARATOR

1 pill orally daily

Other: Sugar pill

Lactobacillus GG

ACTIVE COMPARATOR

1 pill (2 x 10x 9 CFU) daily orally

Dietary Supplement: Lactobacillus GG

Interventions

Lactobacillus GG DIETARY_SUPPLEMENT

probiotic supplement

Also known as: Culturelle

Lactobacillus GG

Sugar pill OTHER

placebo

Sugar Pill

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

OUHSC

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive; Pneumonia

Interventions

Sugars

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Karen S Allen, MD

  OUHSC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2014
• First Posted: July 9, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 23, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)