The Gut-lung Axis in Chronic Obstructive Pulmonary Disease

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Dynamic Changes of the Respiratory Microbiota and Its Relationship to Fecal Microbiota in Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03236480
• Other study ID #: 2109901
• Secondary ID: 2016YFC0903800
• Status: Recruiting
• Phase: N/A
• First received: July 28, 2017
• Last updated: July 28, 2017
• Start date: January 1, 2017
• Est. completion date: January 1, 2019

Study information

• Verified date: July 2017
• Source: Peking University People's Hospital
• Contact: Yali Zheng, Dr.
• Phone: +8615011451515
• Email: yali_zheng[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2019
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Disease
• Immunity, Mucosal
• Lung Diseases
• Lung Diseases, Obstructive
• Metabolism
• Microbiota
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University People's Hospital	Ningde City Hospital, Fujian, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all-cause mortality	all-cause death after the enrollment	patients will be followed for 3 months after their remission from hospital
Secondary	exacerbations	exacerbations of COPD	during the 3-month follow-up