Identification of Microbiome and Metabolome of Bronchiectasis in Chinese Population.

NCT04490447 | Unknown

• 1 other identifier: 20190403
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Lung microbiome of bronchiectasis patient.

  12 months

• BSI (Bronchiectasis Severity Index) score

  2 months

• Lung function

  12 months

• Sputum bacteriological evaluation.

  12 months

• Chest high-resolution computed tomography (CT).

  12 months

Study Arms (2)

Bronchiectasis

Patient meets diagnose of bronchiectasis refering to "BTS guideline 2010" will be included.

Healthy control

Healthy volunteers will be included.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (1)

Shanghai Pulmonary Hospital , Tongji University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 36403022 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

faecal samples for 16S rRNA sequencing and LC-MS analysis.

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Officials

• Jin-fu Xu, MD

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin-fu Xu, MD

CONTACT

+86 13321922898; jfxucn@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of respiratory medicine

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: July 29, 2020
• Study Start: August 1, 2019
• Primary Completion: June 22, 2021
• Study Completion: September 1, 2021
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

CN (1)