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Characteristics of gut microecology in asthma patients with different airflow obstruction phenotypes

Characteristics of gut microecology in asthma patients with different airflow obstruction phenotypes

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200058719
Enrollment
Unknown
Registered
2022-04-15
Start date
2022-04-15
Completion date
Unknown
Last updated
2024-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial Asthma

Interventions

Fixed airflow obstruction asthma group:Nil
Reversible airflow obstruction asthma group:
Healthy control group:Nil

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria of asthma group with fixed airflow obstruction: 1. Age 40-80, male or female; 2. Deny smoking history or smoking cessation for more than 3 years and previous smoking index<15 packs/year, and deny occupational dust and smoke exposure history; 3. It conforms to the diagnostic criteria for asthma in GINA 2020 and China's Guidelines for the Prevention and Treatment of Bronchial Asthma. The duration of the disease is = 5 years, and it has been diagnosed and treated regularly for more than 1 year. At present, the severity is moderate or severe, and the staging is chronic; 4. The recent pulmonary function report indicates that the pulmonary ventilation dysfunction is mainly obstructive, and FEV1/FVC is less than 0.7 after the administration of bronchodilator; 5. The subject signed a written informed consent to participate in the study. Inclusion criteria of reversible airflow obstruction asthma group: 1. Age 40-80, male or female; 2. Deny smoking history or smoking cessation for more than 3 years and previous smoking index<15 packs/year, and deny occupational dust and smoke exposure history; 3. It conforms to the diagnostic criteria for asthma in GINA 2020 and China's Guidelines for the Prevention and Treatment of Bronchial Asthma. The duration of the disease is = 5 years, and it has been diagnosed and treated regularly for more than 1 year. At present, the severity is moderate or severe, and the staging is chronic,; 4. The recent pulmonary function report indicates that the pulmonary ventilation dysfunction is mainly obstructive, and FEV1/FVC = 0.7 after the administration of bronchodilator; 5. The subject signed a written informed consent to participate in the study. Inclusion criteria of healthy control group: 1. Age 40-80, male or female; 2. Deny smoking history or smoking cessation for more than 3 years and previous smoking index<15 packs/year, and deny occupational dust and smoke exposure history; 3. Normal pulmonary function, no history of basic lung diseases; 4. The subject signed a written informed consent to participate in the trial.

Exclusion criteria

Exclusion criteria: Exclusion criteria for fixed airflow obstruction asthma group and reversible airflow obstruction asthma group: 1. Complicated with pneumonia, pulmonary interstitial fibrosis, active pulmonary tuberculosis, obstructive sleep apnea hypopnea syndrome and other respiratory system related diseases, with a previous history of pulmonary surgery; 2. Accompanied by the following diseases or conditions: serious, progressive or uncontrolled diseases of cardiovascular, liver, kidney, hematopoietic system and nervous system; Malignant tumor; Or immunosuppression (including immunosuppression or HIV infection); 3. Accompanied with severe gastrointestinal diseases (such as inflammatory bowel disease [IBD] or irritable bowel syndrome [IBS]), severe diarrhea (more than 3 watery stools lasting for more than 3 days) and constipation (less than 2 stools per week with difficulty in defecation) in the last 3 weeks; 4. Systemic application of antibiotics, systemic glucocorticoids (including oral, intravenous [IV] or intramuscular [IM]), microecological agents or traditional Chinese medicine in the last 4 weeks; 5. Overweight (BMI>28.0kg/m2), pregnant and lactating women; 6. Poor compliance, unable to cooperate with clinical observation and specimen collection. Exclusion criteria for healthy control group: 1. Suffering from hypertension, diabetes, coronary heart disease, liver and kidney failure, nervous system disease, mental disease, malignant tumor, etc; Or immunosuppression (including immunosuppression or HIV infection); 2. Accompanied with severe gastrointestinal diseases (such as inflammatory bowel disease [IBD] or irritable bowel syndrome [IBS]), severe diarrhea (more than 3 watery stools lasting for more than 3 days) and constipation (less than 2 stools per week with difficulty in defecation) in the last 3 weeks; 3. Systemic application of antibiotics, systemic glucocorticoids (including oral, intravenous [IV] or intramuscular [IM]), microecological agents or traditional Chinese medicine in the last 4 weeks; 4. Overweight (BMI>28.0kg/m2), pregnant and lactating women; 5. Poor compliance, unable to cooperate with clinical observation and specimen collection.

Design outcomes

Primary

MeasureTime frame
Microbial species via 16s rRNA;sputum cell count;Scale of Classification and Determination of Constitution in Traditional Chinese Medicine;Pulmonary Function;YKL-40;

Secondary

MeasureTime frame
routine analysis of blood;BMI; clinical characteristics;Serum total IgE;FeNO;

Countries

China

Contacts

Public ContactYinji Xu

Guangdong Provincial Hospital of Chinese Medicine

xuyinji@163.com+86 13826173153

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026