COPDNCT02185092
Probiotic Use in Patients With Prior COPD Exacerbation
A study testing Lactobacillus GG and Sugar pill in people with COPD and Obstructive Lung Disease, run by University of Oklahoma at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- COPD, Obstructive Lung Disease
- What is being tested?
- Lactobacillus GG and Sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Lactobacillus GG, Sugar pill
- Keywords
- exacerbations, COPD, pneumonia, probiotic
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus GGDietary supplement
Also called Culturelle
probiotic supplement
Sugar pillOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| Sugar Pill | Placebo comparator | 1 pill orally daily Receives: Other: Sugar pill |
| Lactobacillus GG | Active comparator | 1 pill (2 x 10x 9 CFU) daily orally Receives: Dietary Supplement: Lactobacillus GG |
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD exacerbations
The primary end point will be the number of COPD exacerbations.
Measured: 1 year
Secondary outcomes (1)
Antibiotic Use
Decreased oral or IV antibiotic use
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Why it stopped: Lost funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen S Allen, MD, Principal investigator, OUHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185092
- Sponsor's protocol ID
- 4258
- Other IDs
- RSRCH032089
- Status last verified
- May 2017
- First submitted
- 3 Jul 2014
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotic Use in Patients With Prior COPD Exacerbation
- ClinicalTrials.gov ID
- NCT02185092
- Acronym / sponsor ID
- 4258
- Conditions
- COPD, Obstructive Lung Disease
- Keywords
- exacerbations, COPD, pneumonia, probiotic
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lost funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to examine the hypothesis test that probiotics will reduce the frequency of exacerbation in patients with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar Pill | Placebo comparator | Other: Sugar pill1 pill orally daily |
| Lactobacillus GG | Active comparator | Dietary Supplement: Lactobacillus GG1 pill (2 x 10x 9 CFU) daily orally |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus GGAlso: Culturelleprobiotic supplement | Dietary supplement | Lactobacillus GG |
| Sugar pillplacebo | Other | Sugar Pill |
Primary outcome
COPD exacerbations
Time frame: 1 year
The primary end point will be the number of COPD exacerbations.
1 secondary outcome
Antibiotic Use
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen S Allen, MD principal investigator
OUHSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus GG and Sugar pill in people with COPD and Obstructive Lung Disease, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COPD exacerbations (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2017.