Chronic obstructive pulmonary disease
Conditions
Interventions
COPD group in stable stage, COPD group in acute exacerbation stage:Fecal microbial transplantation
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: Stable COPD Selection Criteries Each subject must meet all of the following criteria to be included in the study. 1. Signed written informed consent. 2. At the time of visit 1, the applicant should be at least 40 years old, but less than 80 years old. 3. In order to participate in the study, female subjects must either be infertile (i.e., physically incapable of pregnancy, including women who have been through menopause for 2 years) or have no pregnancy plans. 4. Diagnosis of COPD: Based on the definition of the guidelines for diagnosis and treatment of COPD formulated by the Respiratory Society of the Chinese Medical Association in 2013 [13], subjects with a history of COPD are known to have the following characteristics: progressive airflow limitation, which is related to abnormal inflammatory response of the lungs to harmful particles or gases, mainly caused by smoking. 5. Tobacco use: current or former smokers with a continuous smoking history of more than 1 year. 6. COPD Severity: For subjects with a known clinical history of COPD, the severity was defined as follows: pulmonary function results in Visit 1 or 12 months prior to Visit 1, FEV1/FVC ratio <0.70 after bronchodilator administration and FEV1 < 80% normal expected value. Reliable pulmonary ventilation function examination report must be provided within 12 months prior to enrollment. 7. Subjects are willing and able to complete the follow-up according to the plan. 8. Subjects can cooperate to complete relevant examination items. 9. Chest/lung X-ray or computed tomography (CT) scan results within 12 months prior to visit 1 must be acceptable to the investigator. Subjects whose chest X-ray shows clinically significant abnormality, but the abnormality is not caused by COPD, shall not be enrolled. 10. Compliance: Subjects must be willing to return to the hospital and complete all visits and evaluations according to the protocol. Inclusion criteria for acute COPD phase (acute exacerbation COPD): 1. Signed written informed consent. 2. At the time of visit 1, the applicant should be at least 40 years old, but less than 80 years old. 3. In order to participate in the study, female subjects must either be infertile (i.e., physically incapable of pregnancy, including women who have been through menopause for 2 years) or have no pregnancy plans. 4. Acute exacerbation of AECOPD was defined as daily changes of COPD symptoms lasting for 2 days or more, exceeding normal daytime changes, acute occurrence, and possible need to change routine medication. Symptom changes must include the presence of at least one major COPD symptom and at least one of the following other minor symptoms: Major COPD symptoms: difficulty breathing, sputum volume, and sputum color. Minor COPD symptoms: cough, wheezing, sore throat, cold symptoms (runny nose or nasal congestion), and fever with no other cause. 5. Tobacco use: current or former smokers with a continuous smoking history of more than 1 year. 6. COPD Severity: For subjects with a known clinical history of COPD, the severity was defined as follows: pulmonary function results in Visit 1 or 12 months prior to Visit 1, FEV1/FVC ratio < 0.70 after bronchodilator administration and FEV1 <80% normal expected value. Reliable pulmonary ventilation function examination report must be provided within 12 months prior to enrollment. 7. Subjects are willing and able to complete the follow-up according to the plan. 8. Subjects can cooperate to
Exclusion criteria
Exclusion criteria: COPD Stable Exclusion Criteria Subjects meeting any of the following criteria should be excluded from this study: 1.Having a significant disease or condition other than COPD that, in the Investigator's judgment, would put the subject at risk for participating in the study or affect the study outcome and the subject's ability to participate in the study. 2. Women who are pregnant or breastfeeding or who plan to become pregnant during the study period. 3. Digestive system: (1) Patients with known gastrointestinal organic diseases. (2) Complicated with intestinal double infection, such as Clostridium difficile infection, EHEC, Salmonella, Shigella, Campylobacter, plague and cytomegalovirus; (3) patients with various acute infections, tumors, severe arrhythmias, mental disorders, drug or alcohol addiction; (4) pregnant or lactating women; (5) Use of antibiotics or probiotics within the last 4 weeks; (6) There are taboo witnesses for this study; (7) Clinical investigators who were conducting other related COPD studies at the time of enrollment or within 3 months before enrollment; 4. Control factors for COPD: (1) Admission: Subjects admitted to the hospital for poor COPD control within 1 month before visit 1 (screening) or during the screening period (visit 1 to visit 2). (2) Poor control of COPD: Subjects with poor control of COPD were defined as those requiring oral glucocorticoids or antibiotics for acute exacerbation of COPD during the 4 weeks prior to visit 1 (screening). (3) The recovery of upper respiratory tract infection (URTI) was less than 7 days before screening. (4) Pneumonia risk factors: immunosuppression (HIV), severe neurological disease that affects control of the upper respiratory tract, or other risk factors considered by the investigator to place the subject at significant risk of pneumonia. (5) The pneumonia did not recover clinically within 14 days before the first visit. (6) COPD inhaled drug regimen and oral bronchiectasis remained unchanged for at least 4 weeks. 5. Complicated with serious primary diseases of heart, liver, kidney, hematopoietic system and other important organs or systems. 6. Patients with lower back, chest and abdomen injuries or after surgery. 7. People with mental disorder or cognitive impairment. 8. Non-compliance: Subjects did not follow the study procedures, including non-compliance to complete the journal. 9. Informed consent validity is in doubt: Subjects with a history of psychosis, mental retardation, poor motivation, substance abuse (including drugs and alcohol), or other medical conditions that limit the effectiveness of informed consent in this study. 10. Obesity (BMI >= 28) Hyperlipidemia (1.5 times the upper limit of normal value of plasma total cholesterol > or 1.5 times the upper limit of normal value of triglyceride BBB>; Confirmed diabetic patients; Diagnosed cancer patients; Have used any antibiotics or antibiotics in the last 2 weeks; Exclusion criteria for the acute phase of COPD 1. Having a significant disease or condition other than AEOPD that, in the investigator's judgment, would put subjects at risk for participating in the study, or that would affect study results and subjects' ability to participate in the study. 2. Women who are pregnant or breastfeeding or who plan to become pregnant during the study period. 3. Digestive system: (1) patients with known gastrointestinal organic diseases. (2) Complicated with intestinal double infecti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intestinal flora; | — |
Countries
china
Contacts
Public ContactZheng Zeguang
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed