The Gut-lung Axis in Chronic Obstructive Pulmonary Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03236480
Recruitment Status : Recruiting
First Posted : August 2, 2017
Last Update Posted : August 2, 2017
Ningde City Hospital, Fujian, China
Information provided by (Responsible Party):
Peking University People's Hospital

Brief 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). 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.

Condition or disease
Pulmonary Disease, Chronic Obstructive Microbiota Immunity, Mucosal Metabolism

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Dynamic Changes of the Respiratory Microbiota and Its Relationship to Fecal Microbiota in Chronic Obstructive Pulmonary Disease
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : July 1, 2018
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

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

Primary Outcome Measures :
  1. all-cause mortality [ Time Frame: patients will be followed for 3 months after their remission from hospital ]
    all-cause death after the enrollment

Secondary Outcome Measures :
  1. exacerbations [ Time Frame: during the 3-month follow-up ]
    exacerbations of COPD

Biospecimen Retention:   Samples With DNA
1.Lower respiratory tract specimens including sputum, endotracheal aspiration and bronchoalveolar lavage fluid. 2.Peripheral whole blood samples 3.fecal samples

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03236480

Contact: Yali Zheng, Dr. +8615011451515

China, Beijing
Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100044
Contact: Yali Zheng, Dr    15011451515 ext 86   
Sponsors and Collaborators
Peking University People's Hospital
Ningde City Hospital, Fujian, China
Study Chair: Zhancheng Gao, Pro. Peking University People's Hospital

Responsible Party: Peking University People's Hospital Identifier: NCT03236480     History of Changes
Other Study ID Numbers: 2109901
2016YFC0903800 ( Other Grant/Funding Number: Ministery of science and technology of China )
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes