BronchiectasisNCT04490447
Identification of Microbiome and Metabolome of Bronchiectasis in Chinese Population.
An observational study of Bronchiectasis, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bronchiectasis
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Written informed consent
- Regular bowel movement: every 2 days - 3 times/ day
- The diagnose of bronchiectasis should refer to "BTS guideline 2010"
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital , Tongji University
Shanghai, Shanghai Municipality, 200000
Kai-xing Ai, +86-021-65115006
About this study
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.
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.
Read the 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.
- Conditions
- Bronchiectasis
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bronchiectasis | Patient meets diagnose of bronchiectasis refering to "BTS guideline 2010" will be included. | |
| Healthy control | Healthy volunteers will be included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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
Measured: 12 months
Sputum bacteriological evaluation.
Sputum bacteriological (pseudomonas aeruginosa and other organisms) will be evaluated.
Measured: 12 months
Chest high-resolution computed tomography (CT).
Chest high-resolution computed tomography (CT) results in the recent 6 months will be documented.
Measured: 12 months
Acute exacerbation
The time of acute exacerbation in the following year will be recorded according to medical information.
Measured: 12 months
Hospitalization
The time of hospitalization in the following year will be recorded according to medical information.
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start1 Aug 2019
- Primary completion22 Jun 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Fu Xu, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Jin-fu Xu, MD, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490447
- Sponsor's protocol ID
- 20190403
- Status last verified
- Feb 2021
- First submitted
- 24 Apr 2020
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 36403022
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04490447
- Acronym / sponsor ID
- 20190403
- Conditions
- Bronchiectasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 22 Jun 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 29 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bronchiectasis | – | –Patient meets diagnose of bronchiectasis refering to "BTS guideline 2010" will be included. |
| Healthy control | – | –Healthy volunteers will be included. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Written informed consent
- Regular bowel movement: every 2 days - 3 times/ day
- The diagnose of bronchiectasis should refer to "BTS guideline 2010"
Key exclusion criteria (8 listed)
- Diagnosis of ABPA
- Pregnancy or lactation
- Active smoking or alcohol using within last 6 months
- HIV infection
- Previous abdominal or rectal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gut microbiome and metabolomics of bronchiectasis patients and healthy control.
Time frame: 12 months
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.
8 secondary outcomes
Lung microbiome of bronchiectasis patient.
Time frame: 12 months
BSI (Bronchiectasis Severity Index) score
Time frame: 2 months
Lung function
Time frame: 12 months
Sputum bacteriological evaluation.
Time frame: 12 months
Chest high-resolution computed tomography (CT).
Time frame: 12 months
Acute exacerbation
Time frame: 12 months
Hospitalization
Time frame: 12 months
Duration to the first exacerbation during the one-year follow up.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Derived from this study: PubMed 36403022Wang 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.
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Bronchiectasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-fu Xu, MD principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin-fu Xu, MD (+86 13321922898, jfxucn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiome and metabolomics of bronchiectasis patients and healthy control. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04490447, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.