Characteristics of Intestinal Microbiome in the Progression of Early COPD

May 6, 2021 updated by: Second Affiliated Hospital of Xi'an Jiaotong University

Characteristics of Intestinal Microbiome in the Progression of Early Chronic Obstructive Pulmonary Disease

This study is aiming at explore the characteristics of intestinal microbiome during the early progression of COPD, the correlation between the changes of intestinal microbiome and the severity and risk of acute exacerbation of COPD, the correlation between microbial metabolites SCFA and immune function of COPD. Then reveal the influence of intestinal microecology on the development of COPD and the possible mechanism of intestinal microecology in the pathogenesis of COPD.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

  1. Invite participants according to inclusion criteria and exclusion criteria and divide them into 4 groups, including healthy control (HC), high-risk COPD group (HG), early COPD group (EG), mild and moderate COPD group (MG). Research contents will be explained detailedly to the participants, and the healthy participants and COPD patients who volunteer to participate in this study will sign the informed consent form (ICF) under the premise of adequate understanding.
  2. Collect clinical data of the participants and asses the severity of symptoms and the risk of acute exacerbation of COPD patients. Clinical data include general condition, history of past illness, history of present illness, personal history, family history and the examination results of blood routine, pulmonary function and compatible computed tomography. Breathlessness measurement adopt the modified British Medical Reseach Council (mMRC); symptoms measurement adopt COPD assessment test (CAT); quality of life measurement adopt St. George's Respiratory Questionnaire (SGRQ); risk of acute exacerbation measurement adopt dyspnea，degree of airflow obstruction，smoking status and the number of exacerbation (DOSE) scoring system.
  3. Collect fecal specimens from the participants on the morning of the same day. During the first three days of collection, they should keep their daily dietary habits and avoid sudden changes in dietary habits. Considerations: first remove the urine, excrement into a clean dry container, do not mix with urine and other sundries; the part of the feces that do not contact the air and container is taken from the specimen; women who are menstruating cannot be sampled. Each participant collect 3 fecal samples with a sterile spoon in a sterile enzyme-free cryopreservation tube, label the sample name and date, quickly placed in a -20℃ refrigerator, and transported to the hospital within 2 hours, where they were stored at -80℃. Fecal microbiome are detected by 16S rRNA gene sequencing and metabolite short chain fatty acid (SCFA) are detected by Gaschromatography (GC).
  4. Serum of participants are collected at the clinical laboratory and detect indicators related to immune function by enzyme-linked immunosorbent assay (ELISA).
  5. Explore the characteristics of intestinal microbiome during the early progression of COPD, the correlation between the changes of intestinal microbiome and the severity and risk of acute exacerbation of COPD, the correlation between microbial metabolites SCFA and immune function of COPD.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000
        • Second Affiliated Hospital of Xi'an JiaoTong University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yun Liu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants are from Physical Examination Department and Respiratory and Critical Care Medicine Department of the Second Affiliated Hospital of Xi 'an Jiaotong University.

Description

Inclusion Criteria:

  1. ≥10 pack-years smoking history;
  2. Examination of pulmonary function and compatible computed tomography meeting group requirements (as shown in Groups and Interventions).

Exclusion Criteria:

  1. Take antibiotics, probiotics, prebiotics, synbiotics and other drugs that obviously interfere with intestinal microbiome within 2 months;
  2. Suffer from other chronic respiratory diseases other than COPD (such as bronchial asthma, allergic rhinitis, pulmonary interstitial fibrosis, bronchiectasis, lung cancer, etc.);
  3. Suffer from severe intestinal diseases (such as inflammatory bowel disease, intestinal infections, colorectal cancer, etc.);
  4. Suffer from serious hematopoietic system diseases, and the brain, heart, liver, kidney and other important organs are damaged;
  5. Suffer from severe hypertension, coronary heart disease, diabetes and other chronic diseases and taking drugs for long-term maintenance;
  6. Suffer from active infectious diseases (hepatitis B, tuberculosis, etc.);
  7. Pregnant or lactating women;
  8. Patients with obvious anxiety, depression and other psychiatric symptoms and patients with schizophrenia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
HC，healthy control
18-65 years old，no smoking history，normal pulmonary function，normal compatible computed tomography.
HG，high-risk COPD group
18-60 years old，≥10 pack-years smoking history，normal pulmonary function，normal compatible computed tomography.
EG，early COPD group

18-60 years old，≥10 pack-years smoking history，and with any of the following abnormalities：

  1. Forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) less than 80%;
  2. Compatible computed tomography abnormalities：airway abnormality and/or emphysema，air trapping, or bronchial thickening；
  3. FEV1 decline (≥60 mL per year).
MG，mild and moderate COPD group
18-65 years old，FEV1/FVC<70%，FEV1%predicted ≥50%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breathlessness measurement
Time Frame: 1 month
modified British Medical Reseach Council (mMRC)：the score increases from 0 to 4，and higher scores mean a heavier symptom.
1 month
Symptoms measurement
Time Frame: 1 month
COPD assessment test (CAT)：the score increases from 0 to 40，and higher scores mean a heavier symptom.
1 month
Quality of life measurement
Time Frame: 1 month
St. George's Respiratory Questionnaire (SGRQ): the score increases from 0 to 100，and higher scores mean a heavier symptom.
1 month
Risk of acute exacerbation of participants
Time Frame: 1 month
dyspnea，degree of airflow obstruction，smoking status，the number of exacerbation (DOSE): the score increases from 0 to 9，and higher scores mean a higher risk of acute exacerbation.
1 month
Pulmonary function
Time Frame: 1 month
Forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC), FEV1%predicted, MMEF25-75%: range from 0%-100%, and higher percentages mean a heavier symptom.
1 month
Compatible computed tomography
Time Frame: 1 month
mean lung density
1 month
Characteristics of intestinal microbiome
Time Frame: 1 month
Alpha diversity，Beta diversity，Species differences between groups at different taxonomic levels.
1 month
Contents of short chain fatty acid in fecal samples
Time Frame: 1 month
acetic acid, propionic acid, butyric acid
1 month
Blood routine
Time Frame: 1 month
neutrophilic granulocyte percent, eosinophilic granulocyte percent: higher percentages mean a heavier symptom.
1 month
Concentration of protein in serum
Time Frame: 1 month
fibrinogen, C-reactive protein, surfactant protein-D(SP-D)
1 month
Concentration of enzyme in serum
Time Frame: 1 month
neutrophil elastase, alpha1-antitrypsin
1 month
Concentration of inflammatory factor in serum
Time Frame: 1 month
TNF-α, IFN-γ, IL-6, IL-8, IL-17
1 month
Concentration of chemokine in serum
Time Frame: 1 month
CCL-16, CCL-18
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

Collaborators

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Investigators

  • Study Chair: Yun Liu, MD, Second Affiliated Hospital of Xi'an JiaoTong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2021

Primary Completion (ANTICIPATED)

April 1, 2022

Study Completion (ANTICIPATED)

July 1, 2022

Study Registration Dates

First Submitted

April 25, 2021

First Submitted That Met QC Criteria

May 4, 2021

First Posted (ACTUAL)

May 7, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 10, 2021

Last Update Submitted That Met QC Criteria

May 6, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MR-61-21-012951

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to share with others the deidentified individual-patient data (IPD) underlying the results presented in the article (including tables, figures, and appendices or supplementary material).

IPD Sharing Time Frame

Immediately following publication; no end date

IPD Sharing Access Criteria

We plan to share with anyone who wishes to access the data for any purpose of analyses and data are available indefinitely.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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