The Gut-lung Axis in Chronic Obstructive Pulmonary Disease

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.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Disease, Chronic Obstructive; Microbiota; Metabolism; Immunity, Mucosal

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Yali Zheng, Dr.; Phone Number: +8615011451515; Email: yali_zheng@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
all-cause mortality	all-cause death after the enrollment	patients will be followed for 3 months after their remission from hospital

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
exacerbations	exacerbations of COPD	during the 3-month follow-up

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Collaborators: Ningde City Hospital, Fujian, China
• Investigators: Study Chair: Zhancheng Gao, Pro., Peking University People's Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ANTICIPATED): July 1, 2018
• Study Completion (ANTICIPATED): January 1, 2019

Study Registration Dates

• First Submitted: July 28, 2017
• First Submitted That Met QC Criteria: July 28, 2017
• First Posted (ACTUAL): August 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 2, 2017
• Last Update Submitted That Met QC Criteria: July 28, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2109901; 2016YFC0903800 (OTHER_GRANT: Ministery of science and technology of China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No