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A Study on the Effect and Safety of Fecal Microbiota Transplantation in Patients with Acute Exacerbation of COPD

Potential Efficacy and Safety of Fecal Microbiota Transplantation in Patients with Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Multicenter, Prospective Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110513
Enrollment
Unknown
Registered
2025-10-14
Start date
2025-10-20
Completion date
Unknown
Last updated
2025-10-20

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

Conditions

Chronic Obstructive Pulmonary Disease :COPD.

Interventions

Conventional Treatment Group:Patients will receive standard therapy for acute exacerbation of COPD according to the 2024 GOLD guideline.
Conventional Treatment plus Fecal Microbiota Transplantation Group:Patients will receive standard therapy for acute exacerbation of COPD according to the 2024 GOLD guideline, in combination with fecal

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 80 years, regardless of sex. 2. Meeting the diagnostic criteria for acute exacerbation of COPD according to GOLD 2024. 3. Patients with an mMRC score >= 2 or a CAT score >= 10, and eligible for nasojejunal or colonic catheterization. 4. Patients or their legal representatives are able to understand the study protocol, willing to participate, and have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Known allergy to any component of the investigational product used in this study. 2. Presence of major diseases or conditions other than COPD which, in the opinion of the investigator, may expose the subject to increased risk from participation or interfere with study results or the subject’s ability to participate. 3. Gastrointestinal diseases: (1) Patients with known organic gastrointestinal diseases; (2) Patients with concurrent intestinal co-infections, such as *Clostridium difficile*, enterohemorrhagic *Escherichia coli*, *Salmonella*, *Shigella*, *Campylobacter*, *Yersinia*, or cytomegalovirus. 4. Pregnant or lactating women. 5. Patients with a history of gastrointestinal or pulmonary surgery. 6. Participation in another COPD-related clinical trial at the time of enrollment or within 3 months prior to enrollment; or the presence of severe primary diseases involving the heart, liver, kidney, hematopoietic system, or other major organs/systems. 7. Patients with congenital or acquired immunodeficiency. 8. Patients who have received cytotoxic drugs such as rituximab, cyclophosphamide, or methotrexate within the past 3 months. 9. Patients with long-term (= 4 weeks) use of medium- to high-dose corticosteroids. 10. Severe immunosuppression, e.g., neutrophil count < 0.5 × 10?/L. 11. Participation in other clinical trials that may interfere with the evaluation of this study. 12. Any other condition that, in the judgment of the investigator, makes the subject unsuitable for participation.

Design outcomes

Primary

MeasureTime frame
Complete Blood Count (CBC);Inflammatory markers (e.g., C-reactive Protein [CRP], Procalcitonin [PCT]);Routine Biochemical Tests;Arterial Blood Gas Analysis (ABG);Pulmonary Function Test (PFT);Pulmonary Imaging Examination;Modified Medical Research Council (mMRC) Dyspnea Scale Assessment;COPD Assessment Test (CAT) Evaluation;

Secondary

MeasureTime frame
Immune Function Markers;Cardiac Enzyme Profile;D-dimer;B-type Natriuretic Peptide (BNP);

Countries

China

Contacts

Public ContactLi Jiabin

The First Affiliated Hospital of Anhui Medical University

lijiabin@ahmu.edu.cn+86 189 5601 8570

Outcome results

None listed

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