Pulmonary Disease, Chronic ObstructiveNCT03236480
The Gut-lung Axis in Chronic Obstructive Pulmonary Disease
An observational study of Pulmonary Disease, Chronic Obstructive and Microbiota, run by Peking University People's Hospital at 1 site in China.
Trial summary
Patients with chronic obstructive pulmonary disease (COPD) are 2-3 times more likely to occur together with chronic gastrointestinal tract (GIT) diseases, such as inflammatory bowel disease (IBD) or irritable bowel syndrome (IBS). Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Microbiota, Immunity, Mucosal
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 1 Jan 2019
- Phase
- Observational
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients admitted to Peking University People's Hospital and Ningde City Hospital with an exacerbation of COPD between January 2017 and January 2019 will be enrolled.
Who may be able to join
- admitted to hospital with an exacerbation of COPD;
- with no history of probiotics taken;
- the duration of antibiotics treatment before enrollment should be less than 72 hours.
Who cannot join
- being immunocompromised, including history of glucocorticoid taken for more than 1 month, history of immunosuppressive therapy, history of human immunodeficiency virus (HIV) infection, solid tumor or hematological malignancy;
- history of long-term nursing home stays;
- history of recently hospitalized (<90 days).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Yali Zheng, Dr, 15011451515 ext. 86, drylzheng@gmail.com
About this study
Official title: Dynamic Changes of the Respiratory Microbiota and Its Relationship to Fecal Microbiota in Chronic Obstructive Pulmonary Disease
Patients with chronic obstructive pulmonary disease (COPD) are 2-3 times more likely to occur together with chronic gastrointestinal tract (GIT) diseases, such as inflammatory bowel disease (IBD) or irritable bowel syndrome (IBS). Similarly, despite many patients have no history of acute or chronic respiratory disease, up to 50% of IBD patients and 33% of IBS patients have pulmonary involvement, such as inflammation or impaired lung function. Increasing evidence indicated chronic gut and lung disease share key conceptual features with the disorder and dysregulation of the microbial ecosystem. However, the underlying mechanisms are not well understood.
Our study is aimed to elucidate the intimate relationship between the gastrointestinal tract and respiratory tract, and uncover the mechanisms by which the gut microbiota affects the immune responses in the lungs, and vice versa.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COPD | Patients who admitted to Peking Universtiy People's Hospital and Ningde City Hospital between January 2017 and January 2019 with AECOPD will be enrolled | |
| healthy control | People aged over 40, without any chronic respiratory disease or acute respiratory infections in the last 2 weeks, and be willing to participate in the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
all-cause death after the enrollment
Measured: patients will be followed for 3 months after their remission from hospital
Secondary outcomes (1)
exacerbations
exacerbations of COPD
Measured: during the 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start1 Jan 2017
- Primary completion1 Jul 2018 (estimated)
- Study completion1 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ningde City Hospital, Fujian, China
- Responsible party
- Sponsor
- Investigators
- Zhancheng Gao, Pro., Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236480
- Sponsor's protocol ID
- 2109901
- Other IDs
- 2016YFC0903800
- Status last verified
- Jul 2017
- First submitted
- 28 Jul 2017
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Xie Y, Xue Q, Jiao W, Wu J, Yu Y, Zhao L, Xu Y, Deng X, Fang G, Zheng Y, Gao Z. Associations Between Sputum Torque Teno Virus Load and Lung Function and Disease Severity in Patients With Chronic Obstructive Pulmonary Disease. Front Med (Lausanne). 2021 Apr 22;8:618757. doi: 10.3389/fmed.2021.618757. eCollection 2021.
PubMed 33968949
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Changes of the Respiratory Microbiota and Its Relationship to Fecal Microbiota in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03236480
- Acronym / sponsor ID
- 2109901
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Ningde City Hospital, Fujian, China
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- 1 Jan 2019 (estimated)
- First posted
- 2 Aug 2017 (actual)
- 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.
Patients with chronic obstructive pulmonary disease (COPD) are 2-3 times more likely to occur together with chronic gastrointestinal tract (GIT) diseases, such as inflammatory bowel disease (IBD) or irritable bowel syndrome (IBS). Similarly, despite many patients have no history of acute or chronic respiratory disease, up to 50% of IBD patients and 33% of IBS patients have pulmonary involvement, such as inflammation or impaired lung function. Increasing evidence indicated chronic gut and lung disease share key conceptual features with the disorder and dysregulation of the microbial ecosystem. However, the underlying mechanisms are not well understood.
Our study is aimed to elucidate the intimate relationship between the gastrointestinal tract and respiratory tract, and uncover the mechanisms by which the gut microbiota affects the immune responses in the lungs, and vice versa.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD | – | –Patients who admitted to Peking Universtiy People's Hospital and Ningde City Hospital between January 2017 and January 2019 with AECOPD will be enrolled |
| healthy control | – | –People aged over 40, without any chronic respiratory disease or acute respiratory infections in the last 2 weeks, and be willing to participate in the study |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to Peking University People's Hospital and Ningde City Hospital with an exacerbation of COPD between January 2017 and January 2019 will be enrolled.
Key inclusion criteria (3 listed)
- admitted to hospital with an exacerbation of COPD;
- with no history of probiotics taken;
- the duration of antibiotics treatment before enrollment should be less than 72 hours.
Key exclusion criteria (3 listed)
- being immunocompromised, including history of glucocorticoid taken for more than 1 month, history of immunosuppressive therapy, history of human immunodeficiency virus (HIV) infection, solid tumor or hematological malignancy;
- history of long-term nursing home stays;
- history of recently hospitalized (<90 days).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
all-cause mortality
Time frame: patients will be followed for 3 months after their remission from hospital
all-cause death after the enrollment
1 secondary outcome
exacerbations
Time frame: during the 3-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
- Derived from this study: PubMed 33968949Xie Y, Xue Q, Jiao W, Wu J, Yu Y, Zhao L, Xu Y, Deng X, Fang G, Zheng Y, Gao Z. Associations Between Sputum Torque Teno Virus Load and Lung Function and Disease Severity in Patients With Chronic Obstructive Pulmonary Disease. Front Med (Lausanne). 2021 Apr 22;8:618757. doi: 10.3389/fmed.2021.618757. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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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.
Zhancheng Gao, Pro. study chair
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive and Microbiota, run by Peking University People's Hospital at 1 site in China.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 2 Aug 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 China. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yali Zheng, Dr. (+8615011451515, yali_zheng@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality (time frame: patients will be followed for 3 months after their remission from hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03236480, which also lists 1 linked publication.
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 2 Aug 2017.