The Gut-lung Axis in Chronic Obstructive Pulmonary Disease

Sponsor
Peking University People's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03236480
Collaborator
Ningde City Hospital, Fujian, China (Other)
100
1
24
4.2

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Jan 1, 2017
    Anticipated Primary Completion Date :
    Jul 1, 2018
    Anticipated Study Completion Date :
    Jan 1, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. all-cause mortality [patients will be followed for 3 months after their remission from hospital]

      all-cause death after the enrollment

    Secondary Outcome Measures

    1. exacerbations [during the 3-month follow-up]

      exacerbations of COPD

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University People's Hospital Beijing Beijing China 100044

    Sponsors and Collaborators

    • Peking University People's Hospital
    • Ningde City Hospital, Fujian, China

    Investigators

    • Study Chair: Zhancheng Gao, Pro., Peking University People's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking University People's Hospital
    ClinicalTrials.gov Identifier:
    NCT03236480
    Other Study ID Numbers:
    • 2109901
    • 2016YFC0903800
    First Posted:
    Aug 2, 2017
    Last Update Posted:
    Aug 2, 2017
    Last Verified:
    Jul 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    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:

    Study Results

    No Results Posted as of Aug 2, 2017