The Gut-lung Axis in Chronic Obstructive Pulmonary Disease

NCT03236480 | Unknown

• 2 other identifiers: 21099012016YFC0903800
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive; Microbiota; Immunity, Mucosal; Metabolism

Outcome Measures

Primary Outcomes (1)

• all-cause mortality

  all-cause death after the enrollment

  patients will be followed for 3 months after their remission from hospital

Secondary Outcomes (1)

• exacerbations

  during the 3-month follow-up

Study Arms (2)

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 33968949 DERIVED

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

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhancheng Gao, Pro.

  Peking University People's Hospital

  STUDY CHAIR

Central Study Contacts

Yali Zheng, Dr.

CONTACT

+8615011451515; yali_zheng@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: August 2, 2017
• Study Start: January 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: January 1, 2019
• Last Updated: August 2, 2017

Record last verified: 2017-07

Locations

CN (1)