Identification of Microbiome and Metabolome of Bronchiectasis in Chinese Population.

NCT ID: NCT04490447

Last Updated: 2021-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-01

Study Completion Date

2021-09-01

Brief Summary

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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

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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.

Conditions

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Bronchiectasis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Bronchiectasis

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

No interventions assigned to this group

Healthy control

Healthy volunteers will be included.

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role lead

Responsible Party

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Jin-Fu Xu

Director, Head of respiratory medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin-fu Xu, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Pulmonary Hospital, Shanghai, China

Locations

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Shanghai Pulmonary Hospital , Tongji University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jin-fu Xu, MD

Role: CONTACT

+86 13321922898

Facility Contacts

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Kai-xing Ai

Role: primary

+86-021-65115006

References

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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.

Reference Type DERIVED
PMID: 36403022 (View on PubMed)

Other Identifiers

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20190403

Identifier Type: -

Identifier Source: org_study_id

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