Clinical trial NCT04490447: Identification of Microbiome and Metabolome of Bronchiectasis in Chinese Population.
Official title: Identification of Microbiome and Metabolome of Bronchiectasis in Chinese Population and Role of the "Gut-lung Axis" in Chronic Respiratory Infection With Pseudomonas Aeruginosa.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bronchiectasis
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled in this study should meet the diagnositc criteria of BTS guideline 2010" . Patients with a history of antibiotic use were admitted to the study. Healthy volunteers were eligible for inclusion provided they had not received antibiotics within the previous one month.

Brief summary: This study aims to investigate the characteristics of gut microbiome and metabolome in non-CF bronchiectasis patients, hoping to explore the underlying mechanisms as well as the influence of gut microbiota composition on bronchiectasis.

Detailed description: Non-cystic fibrosis bronchiectasis is a chronic airway disease characterized by irreversible and progressive dilation of the large airways, bronchi and bronchioles, which severely impairs the life quality of patients and increases the social and economic burden. It is also a heterogenous disease affected by multiple factors such as geography and ethnicity. The incidence of bronchiectasis among the Chinese population is about 1.2%, which has clearly been underestimated. However, due to the lack of awareness, the research of bronchiectasis in China is still in its infancy. Colonization and recurrent infection of pathogen is the primary unsolved problem in clinical practice. With the proposition of "gut-lung axis" theory, the role of gut microbiota in the pathogenesis of respiratory diseases has been gradually revealed. Evidences have shown that gut microbiota regulates respiratory immunity via releasing soluble bacterial components and its metabolites into the circulation, as well as facilitating the migration of immune cells directly to the lung. In the 1980s, a patient after a colectomy has been reported to generate bronchiectasis. The most common clinical manifestation of pulmonary involved IBD patients is also bronchiectasis, suggesting that the "gut-lung axis" may be involved in the pathogenesis of bronchiectasis. Therefore, clarifying the role and mechanism of gut microbiota in bronchiectasis and its gut microbiome is expected to provide new theoretical basis and ideas for its diagnosis and treatment.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Regular bowel movement: every 2 days - 3 times/ day
* The diagnose of bronchiectasis should refer to "BTS guideline 2010"

Exclusion Criteria:

* Diagnosis of ABPA
* Pregnancy or lactation
* Active smoking or alcohol using within last 6 months
* HIV infection
* Previous abdominal or rectal surgery
* Diagnosis of chronic gastrointestinal disease, heart disease, diabetes, severe renal insufficiency (GFR \< 30ml/min) or immunodeficiency
* Regular use of the following types of medications (\> 2 times per week) within last 2 months: opium, loperamide antidiarrheal, systemic antihistaminic, metoclopramide, proton pump inhibitor
* Poor compliance or inability to cooperate as judged by the doctor

Primary outcomes:
measure: Gut microbiome and metabolomics of bronchiectasis patients and healthy control.
timeFrame: 12 months
Secondary outcomes:
measure: Lung microbiome of bronchiectasis patient.
timeFrame: 12 months
measure: BSI (Bronchiectasis Severity Index) score
timeFrame: 2 months
measure: Lung function
timeFrame: 12 months
measure: Sputum bacteriological evaluation.
timeFrame: 12 months
measure: Chest high-resolution computed tomography (CT).
timeFrame: 12 months
measure: Acute exacerbation
timeFrame: 12 months
measure: Hospitalization
timeFrame: 12 months
measure: Duration to the first exacerbation during the one-year follow up.
timeFrame: 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital , Tongji University
state: Shanghai
Study officials:
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Jin-fu Xu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang WW, Mao B, Liu Y, Gu SY, Lu HW, Bai JW, Liang S, Yang JW, Li JX, Su X, Hu HY, Wang C, Xu JF. Altered fecal microbiome and metabolome in adult patients with non-cystic fibrosis bronchiectasis. Respir Res. 2022 Nov 19;23(1):317. doi: 10.1186/s12931-022-02229-w.