Chronic Obstructive Pulmonary DiseaseNCT04876833
Characteristics of Intestinal Microbiome in the Progression of Early COPD
An observational study of Chronic Obstructive Pulmonary Disease, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- May 2021to Jul 2022
- How long will I take part?
- 1 Month
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- ≥10 pack-years smoking history;
- Examination of pulmonary function and compatible computed tomography meeting group requirements (as shown in Groups and Interventions).
Who cannot join
- Take antibiotics, probiotics, prebiotics, synbiotics and other drugs that obviously interfere with intestinal microbiome within 2 months;
- Suffer from other chronic respiratory diseases other than COPD (such as bronchial asthma, allergic rhinitis, pulmonary interstitial fibrosis, bronchiectasis, lung cancer, etc.);
- Suffer from severe intestinal diseases (such as inflammatory bowel disease, intestinal infections, colorectal cancer, etc.);
- Suffer from serious hematopoietic system diseases, and the brain, heart, liver, kidney and other important organs are damaged;
- Suffer from severe hypertension, coronary heart disease, diabetes and other chronic diseases and taking drugs for long-term maintenance;
- Suffer from active infectious diseases (hepatitis B, tuberculosis, etc.);
- Pregnant or lactating women;
- Patients with obvious anxiety, depression and other psychiatric symptoms and patients with schizophrenia.
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710000
Yun Liu, MD, 0086-13572887605, 27556828@qq.com
Yangfan Hou, 0086-18534899825, 1016429390@qq.com
About this study
Official title: 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.
Read the detailed description
- 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.
- 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.
- 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).
- Serum of participants are collected at the clinical laboratory and detect indicators related to immune function by enzyme-linked immunosorbent assay (ELISA).
- 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, Intestinal Microbiome, Metabolite, Immune Function
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
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 |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Breathlessness measurement
modified British Medical Reseach Council (mMRC)：the score increases from 0 to 4，and higher scores mean a heavier symptom.
Measured: 1 month
Symptoms measurement
COPD assessment test (CAT)：the score increases from 0 to 40，and higher scores mean a heavier symptom.
Measured: 1 month
Quality of life measurement
St. George's Respiratory Questionnaire (SGRQ): the score increases from 0 to 100，and higher scores mean a heavier symptom.
Measured: 1 month
Risk of acute exacerbation of participants
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.
Measured: 1 month
Pulmonary function
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.
Measured: 1 month
Compatible computed tomography
mean lung density
Measured: 1 month
Characteristics of intestinal microbiome
Alpha diversity，Beta diversity，Species differences between groups at different taxonomic levels.
Measured: 1 month
Contents of short chain fatty acid in fecal samples
acetic acid, propionic acid, butyric acid
Measured: 1 month
Blood routine
neutrophilic granulocyte percent, eosinophilic granulocyte percent: higher percentages mean a heavier symptom.
Measured: 1 month
Concentration of protein in serum
fibrinogen, C-reactive protein, surfactant protein-D(SP-D)
Measured: 1 month
Concentration of enzyme in serum
neutrophil elastase, alpha1-antitrypsin
Measured: 1 month
Concentration of inflammatory factor in serum
TNF-α, IFN-γ, IL-6, IL-8, IL-17
Measured: 1 month
Concentration of chemokine in serum
CCL-16, CCL-18
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study startMay 2021 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 120 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yun Liu, MD, Study chair, Second Affiliated Hospital of Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876833
- Sponsor's protocol ID
- MR-61-21-012951
- Status last verified
- May 2021
- First submitted
- 25 Apr 2021
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
Tsay JJ, Segal LN. Could the Sputum Microbiota Be a Biomarker That Predicts Mortality after Acute Exacerbations of Chronic Obstructive Pulmonary Disease? Am J Respir Crit Care Med. 2019 May 15;199(10):1175-1176. doi: 10.1164/rccm.201811-2138ED. No abstract available.
PubMed 30485116Stockley RA, Halpin DMG, Celli BR, Singh D. Chronic Obstructive Pulmonary Disease Biomarkers and Their Interpretation. Am J Respir Crit Care Med. 2019 May 15;199(10):1195-1204. doi: 10.1164/rccm.201810-1860SO.
PubMed 30592902Budden KF, Gellatly SL, Wood DL, Cooper MA, Morrison M, Hugenholtz P, Hansbro PM. Emerging pathogenic links between microbiota and the gut-lung axis. Nat Rev Microbiol. 2017 Jan;15(1):55-63. doi: 10.1038/nrmicro.2016.142. Epub 2016 Oct 3.
PubMed 27694885GBD 2015 Chronic Respiratory Disease Collaborators. Global, regional, and national deaths, prevalence, disability-adjusted life years, and years lived with disability for chronic obstructive pulmonary disease and asthma, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Respir Med. 2017 Sep;5(9):691-706. doi: 10.1016/S2213-2600(17)30293-X. Epub 2017 Aug 16.
PubMed 28822787Wang C, Xu J, Yang L, Xu Y, Zhang X, Bai C, Kang J, Ran P, Shen H, Wen F, Huang K, Yao W, Sun T, Shan G, Yang T, Lin Y, Wu S, Zhu J, Wang R, Shi Z, Zhao J, Ye X, Song Y, Wang Q, Zhou Y, Ding L, Yang T, Chen Y, Guo Y, Xiao F, Lu Y, Peng X, Zhang B, Xiao D, Chen CS, Wang Z, Zhang H, Bu X, Zhang X, An L, Zhang S, Cao Z, Zhan Q, Yang Y, Cao B, Dai H, Liang L, He J; China Pulmonary Health Study Group. Prevalence and risk factors of chronic obstructive pulmonary disease in China (the China Pulmonary Health [CPH] study): a national cross-sectional study. Lancet. 2018 Apr 28;391(10131):1706-1717. doi: 10.1016/S0140-6736(18)30841-9. Epub 2018 Apr 9.
PubMed 29650248Colak Y, Afzal S, Nordestgaard BG, Vestbo J, Lange P. Prevalence, Characteristics, and Prognosis of Early Chronic Obstructive Pulmonary Disease. The Copenhagen General Population Study. Am J Respir Crit Care Med. 2020 Mar 15;201(6):671-680. doi: 10.1164/rccm.201908-1644OC.
PubMed 31770495Bowerman KL, Rehman SF, Vaughan A, Lachner N, Budden KF, Kim RY, Wood DLA, Gellatly SL, Shukla SD, Wood LG, Yang IA, Wark PA, Hugenholtz P, Hansbro PM. Disease-associated gut microbiome and metabolome changes in patients with chronic obstructive pulmonary disease. Nat Commun. 2020 Nov 18;11(1):5886. doi: 10.1038/s41467-020-19701-0.
PubMed 33208745Jang YO, Lee SH, Choi JJ, Kim DH, Choi JM, Kang MJ, Oh YM, Park YJ, Shin Y, Lee SW. Fecal microbial transplantation and a high fiber diet attenuates emphysema development by suppressing inflammation and apoptosis. Exp Mol Med. 2020 Jul;52(7):1128-1139. doi: 10.1038/s12276-020-0469-y. Epub 2020 Jul 17.
PubMed 32681029Sprooten RTM, Lenaerts K, Braeken DCW, Grimbergen I, Rutten EP, Wouters EFM, Rohde GGU. Increased Small Intestinal Permeability during Severe Acute Exacerbations of COPD. Respiration. 2018;95(5):334-342. doi: 10.1159/000485935. Epub 2018 Jan 25.
PubMed 29393240Keely S, Talley NJ, Hansbro PM. Pulmonary-intestinal cross-talk in mucosal inflammatory disease. Mucosal Immunol. 2012 Jan;5(1):7-18. doi: 10.1038/mi.2011.55. Epub 2011 Nov 16.
PubMed 22089028Wypych TP, Wickramasinghe LC, Marsland BJ. The influence of the microbiome on respiratory health. Nat Immunol. 2019 Oct;20(10):1279-1290. doi: 10.1038/s41590-019-0451-9. Epub 2019 Sep 9.
PubMed 31501577Mortaz E, Adcock IM, Ricciardolo FL, Varahram M, Jamaati H, Velayati AA, Folkerts G, Garssen J. Anti-Inflammatory Effects of Lactobacillus Rahmnosus and Bifidobacterium Breve on Cigarette Smoke Activated Human Macrophages. PLoS One. 2015 Aug 28;10(8):e0136455. doi: 10.1371/journal.pone.0136455. eCollection 2015.
PubMed 26317628Reale M, Boscolo P, Bellante V, Tarantelli C, Di Nicola M, Forcella L, Li Q, Morimoto K, Muraro R. Daily intake of Lactobacillus casei Shirota increases natural killer cell activity in smokers. Br J Nutr. 2012 Jul;108(2):308-14. doi: 10.1017/S0007114511005630. Epub 2011 Dec 6.
PubMed 22142891Tomoda K, Kubo K, Dairiki K, Yamaji T, Yamamoto Y, Nishii Y, Nakamura A, Yoshikawa M, Hamada K, Kimura H. Whey peptide-based enteral diet attenuated elastase-induced emphysema with increase in short chain fatty acids in mice. BMC Pulm Med. 2015 Jun 10;15:64. doi: 10.1186/s12890-015-0059-2.
PubMed 26059026Lee SH, Yun Y, Kim SJ, Lee EJ, Chang Y, Ryu S, Shin H, Kim HL, Kim HN, Lee JH. Association between Cigarette Smoking Status and Composition of Gut Microbiota: Population-Based Cross-Sectional Study. J Clin Med. 2018 Sep 14;7(9):282. doi: 10.3390/jcm7090282.
PubMed 30223529
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Intestinal Microbiome in the Progression of Early Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04876833
- Acronym / sponsor ID
- MR-61-21-012951
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, Intestinal Microbiome, Metabolite, Immune Function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Study start
- May 2021 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 7 May 2021 (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 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.
Detailed description
- 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.
- 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.
- 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).
- Serum of participants are collected at the clinical laboratory and detect indicators related to immune function by enzyme-linked immunosorbent assay (ELISA).
- 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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%. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- ≥10 pack-years smoking history;
- Examination of pulmonary function and compatible computed tomography meeting group requirements (as shown in Groups and Interventions).
Key exclusion criteria (8 listed)
- Take antibiotics, probiotics, prebiotics, synbiotics and other drugs that obviously interfere with intestinal microbiome within 2 months;
- Suffer from other chronic respiratory diseases other than COPD (such as bronchial asthma, allergic rhinitis, pulmonary interstitial fibrosis, bronchiectasis, lung cancer, etc.);
- Suffer from severe intestinal diseases (such as inflammatory bowel disease, intestinal infections, colorectal cancer, etc.);
- Suffer from serious hematopoietic system diseases, and the brain, heart, liver, kidney and other important organs are damaged;
- Suffer from severe hypertension, coronary heart disease, diabetes and other chronic diseases and taking drugs for long-term maintenance;
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
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.
Symptoms measurement
Time frame: 1 month
COPD assessment test (CAT)：the score increases from 0 to 40，and higher scores mean a heavier symptom.
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.
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.
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.
Compatible computed tomography
Time frame: 1 month
mean lung density
Characteristics of intestinal microbiome
Time frame: 1 month
Alpha diversity，Beta diversity，Species differences between groups at different taxonomic levels.
Contents of short chain fatty acid in fecal samples
Time frame: 1 month
acetic acid, propionic acid, butyric acid
Blood routine
Time frame: 1 month
neutrophilic granulocyte percent, eosinophilic granulocyte percent: higher percentages mean a heavier symptom.
Concentration of protein in serum
Time frame: 1 month
fibrinogen, C-reactive protein, surfactant protein-D(SP-D)
Concentration of enzyme in serum
Time frame: 1 month
neutrophil elastase, alpha1-antitrypsin
Concentration of inflammatory factor in serum
Time frame: 1 month
TNF-α, IFN-γ, IL-6, IL-8, IL-17
Concentration of chemokine in serum
Time frame: 1 month
CCL-16, CCL-18
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Background: PubMed 30485116Tsay JJ, Segal LN. Could the Sputum Microbiota Be a Biomarker That Predicts Mortality after Acute Exacerbations of Chronic Obstructive Pulmonary Disease? Am J Respir Crit Care Med. 2019 May 15;199(10):1175-1176. doi: 10.1164/rccm.201811-2138ED. No abstract available.
- Background: PubMed 30592902Stockley RA, Halpin DMG, Celli BR, Singh D. Chronic Obstructive Pulmonary Disease Biomarkers and Their Interpretation. Am J Respir Crit Care Med. 2019 May 15;199(10):1195-1204. doi: 10.1164/rccm.201810-1860SO.
- Background: PubMed 27694885Budden KF, Gellatly SL, Wood DL, Cooper MA, Morrison M, Hugenholtz P, Hansbro PM. Emerging pathogenic links between microbiota and the gut-lung axis. Nat Rev Microbiol. 2017 Jan;15(1):55-63. doi: 10.1038/nrmicro.2016.142. Epub 2016 Oct 3.
- Results publication: PubMed 28822787GBD 2015 Chronic Respiratory Disease Collaborators. Global, regional, and national deaths, prevalence, disability-adjusted life years, and years lived with disability for chronic obstructive pulmonary disease and asthma, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Respir Med. 2017 Sep;5(9):691-706. doi: 10.1016/S2213-2600(17)30293-X. Epub 2017 Aug 16.
- Results publication: PubMed 29650248Wang C, Xu J, Yang L, Xu Y, Zhang X, Bai C, Kang J, Ran P, Shen H, Wen F, Huang K, Yao W, Sun T, Shan G, Yang T, Lin Y, Wu S, Zhu J, Wang R, Shi Z, Zhao J, Ye X, Song Y, Wang Q, Zhou Y, Ding L, Yang T, Chen Y, Guo Y, Xiao F, Lu Y, Peng X, Zhang B, Xiao D, Chen CS, Wang Z, Zhang H, Bu X, Zhang X, An L, Zhang S, Cao Z, Zhan Q, Yang Y, Cao B, Dai H, Liang L, He J; China Pulmonary Health Study Group. Prevalence and risk factors of chronic obstructive pulmonary disease in China (the China Pulmonary Health [CPH] study): a national cross-sectional study. Lancet. 2018 Apr 28;391(10131):1706-1717. doi: 10.1016/S0140-6736(18)30841-9. Epub 2018 Apr 9.
- Results publication: PubMed 31770495Colak Y, Afzal S, Nordestgaard BG, Vestbo J, Lange P. Prevalence, Characteristics, and Prognosis of Early Chronic Obstructive Pulmonary Disease. The Copenhagen General Population Study. Am J Respir Crit Care Med. 2020 Mar 15;201(6):671-680. doi: 10.1164/rccm.201908-1644OC.
- Results publication: PubMed 33208745Bowerman KL, Rehman SF, Vaughan A, Lachner N, Budden KF, Kim RY, Wood DLA, Gellatly SL, Shukla SD, Wood LG, Yang IA, Wark PA, Hugenholtz P, Hansbro PM. Disease-associated gut microbiome and metabolome changes in patients with chronic obstructive pulmonary disease. Nat Commun. 2020 Nov 18;11(1):5886. doi: 10.1038/s41467-020-19701-0.
- Results publication: PubMed 32681029Jang YO, Lee SH, Choi JJ, Kim DH, Choi JM, Kang MJ, Oh YM, Park YJ, Shin Y, Lee SW. Fecal microbial transplantation and a high fiber diet attenuates emphysema development by suppressing inflammation and apoptosis. Exp Mol Med. 2020 Jul;52(7):1128-1139. doi: 10.1038/s12276-020-0469-y. Epub 2020 Jul 17.
- Results publication: PubMed 29393240Sprooten RTM, Lenaerts K, Braeken DCW, Grimbergen I, Rutten EP, Wouters EFM, Rohde GGU. Increased Small Intestinal Permeability during Severe Acute Exacerbations of COPD. Respiration. 2018;95(5):334-342. doi: 10.1159/000485935. Epub 2018 Jan 25.
- Results publication: PubMed 22089028Keely S, Talley NJ, Hansbro PM. Pulmonary-intestinal cross-talk in mucosal inflammatory disease. Mucosal Immunol. 2012 Jan;5(1):7-18. doi: 10.1038/mi.2011.55. Epub 2011 Nov 16.
- Results publication: PubMed 31501577Wypych TP, Wickramasinghe LC, Marsland BJ. The influence of the microbiome on respiratory health. Nat Immunol. 2019 Oct;20(10):1279-1290. doi: 10.1038/s41590-019-0451-9. Epub 2019 Sep 9.
- Results publication: PubMed 26317628Mortaz E, Adcock IM, Ricciardolo FL, Varahram M, Jamaati H, Velayati AA, Folkerts G, Garssen J. Anti-Inflammatory Effects of Lactobacillus Rahmnosus and Bifidobacterium Breve on Cigarette Smoke Activated Human Macrophages. PLoS One. 2015 Aug 28;10(8):e0136455. doi: 10.1371/journal.pone.0136455. eCollection 2015.
- Correlation index analysis of intestinal flora and inflammatory factors in patients with chronic obstructive pulmonary diseaseLink provided by the sponsor.
- Characteristics of intestinal flora in patients with chronic obstructive pulmonary disease and their correlation with inflammatory markers and pulmonary function statusLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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).
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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.
Yun Liu, MD study chair
Second Affiliated Hospital of Xi'an Jiaotong University
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 Chronic Obstructive Pulmonary Disease, run by Second Affiliated Hospital of Xi'an Jiaotong University 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 2 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 10 May 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 Yun Liu, MD (0086-13572887605, 27556828@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breathlessness measurement (time frame: 1 month). The study lists 13 primary outcomes in all. 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 NCT04876833, which also lists 16 linked publications.
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 10 May 2021.