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A study on the inflammatory immune mechanism and clinical correlation of intestinal probiotics regulating lung-intestinal axis in pulmonary fibrosis

A study on the inflammatory immune mechanism and clinical correlation of intestinal probiotics regulating lung-intestinal axis in pulmonary fibrosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109525
Enrollment
Unknown
Registered
2025-09-19
Start date
2025-01-07
Completion date
Unknown
Last updated
2025-09-22

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

Conditions

pulmonary fibrosis

Interventions

Control group (44 cases):None
Group of pulmonary fibrosis :None
group of pulmonary fibrosis+Pefephen:Bifidobacteria Triple Viable Capsule, 210mg/capsule, two capsules per day, two capsules per time, taken by mouth for a total of 8 weeks

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Have a previous history of recurrent cough, expectoration, and/or hemoptysis; 2. All patients were diagnosed with pulmonary fibrosis by HRCT and respiratory doctors; 3.Currently in a stable condition, no antibiotics were used for nearly 2 months. 44 controls for lung tumors: 1. No history of chronic respiratory disease; 2.No history of antibiotic drug use; 3.No gastrointestinal and other system diseases

Exclusion criteria

Exclusion criteria: 1. Concomitant with history of Bronchial Asthma, Tuberculosis, Chronic Obstructive Lung Disease, Allergic Aspergillosis and Bronchiectasis; 2. Have a history of autoimmune disease; 3. Have symptoms of abdominal pain, diarrhea, or a history of clearly diagnosed gastrointestinal disease; 4. Have a history of acute and chronic heart, liver, kidney, and tumors; 5. Use of steroids within three months; 6 Coordination difficulties as well as contact difficulties.

Design outcomes

Primary

MeasureTime frame
Acute exacerbation rate;

Secondary

MeasureTime frame
Changes in predominant bacteria in the subject's intestine and lungs;Changes of FVC and DLCO in lung function of subjects;T lymphoid immune cell number of subjects;Number of acute patient hospitalizations;

Countries

China

Contacts

Public ContactHanhan Liu

Shanghai Sixth People's Hospital

lhhssym@163.com+86 189 3017 0038

Outcome results

None listed

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