Identification of Microbiome and Metabolome of Bronchiectasis in Chinese Population.

Identification of Microbiome and Metabolome of Bronchiectasis in Chinese Population and Role of the "Gut-lung Axis" in Chronic Respiratory Infection With Pseudomonas Aeruginosa.

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.

Study Overview

• Status: Recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Shanghai Pulmonary Hospital , Tongji University
      • Contact: Kai-xing Ai; Phone Number: +86-021-65115006

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Bronchiectasis; Patient meets diagnose of bronchiectasis refering to "BTS guideline 2010" will be included.
Healthy control; Healthy volunteers will be included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiome and metabolomics of bronchiectasis patients and healthy control.	The microbiome and metabolome results of gut in bronchiectasis patients will be defined from the stool samples using 16S rRNA Miseq sequencing and nontargeted LC-MS-based metabolomics approach.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung microbiome of bronchiectasis patient.	The bronchoalveolar lavage fluid (BALF) specimens will be obtained from admitted patients undergoing bronchoscopy and the lung microbiome of bronchiectasis patients will be defined from the BALF samples using 16S rRNA Miseq sequencing.	12 months
BSI (Bronchiectasis Severity Index) score	Assessment of the non-cystic fibrosis bronchiectasis severity according to the BSI score at the time of enrollment. BSI score: scale of 0-26, is calculated from the results of age, BMI(body mass index), FEV1% predicted, exacerbations, hospital admissions, airway organisms colonisation, radiological severity etc.) 0-4, 5-8, >9 were separately defined as mild, moderate, severe bronchiectasis, higher score indicates probable higher mortality rate and hospitalisation rate.	2 months
Lung function	Lung function will be accessed by Pulmonary Function Tests (PFT) and the parameters including FVC ( forced vital capacity), FEV1 (forced the first second of expiratory volume), FEV1% predicted, FEV1/FVC will be documented at the time of enrollment	12 months
Sputum bacteriological evaluation.	Sputum bacteriological (pseudomonas aeruginosa and other organisms) will be evaluated.	12 months
Chest high-resolution computed tomography (CT).	Chest high-resolution computed tomography (CT) results in the recent 6 months will be documented.	12 months
Acute exacerbation	The time of acute exacerbation in the following year will be recorded according to medical information.	12 months
Hospitalization	The time of hospitalization in the following year will be recorded according to medical information.	12 months
Duration to the first exacerbation during the one-year follow up.	The duration to the first exacerbation within one year after the sample collection.	24 months

Collaborators and Investigators

• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): June 22, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 18, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis
• Other Study ID Numbers: 20190403

Drug and device information, study documents

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