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A Prospective Observational Study of Respiratory and Gut Microbiomes and Their Relationship with Clinical Outcomes in Idiopathic Pulmonary Fibrosis

Investigating the Microbiome and Metabolites Changes in Idiopathic Pulmonary Fibrosis: Mechanisms and Therapeutic Effects Based on Gut Microbiome Intervention

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0011187
Enrollment
50
Registered
2025-11-21
Start date
2025-05-07
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

None listed

Interventions

None listed

Sponsors

Soon Chun Hyang University Hospital Seoul
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients diagnosed with idiopathic pulmonary fibrosis (IPF) according to ATS/ERS/JRS/ALAT diagnostic guidelines 2) Adults aged 19 years or older who voluntarily provide written informed consent 3) Able to provide required biospecimens (blood, sputum, BALF when clinically indicated, stool, and buccal epithelial cells) 4) Able to comply with study visits and follow-up for at least 12 months

Exclusion criteria

Exclusion criteria: 1) Individuals with cognitive impairment or psychological conditions that interfere with participation in study procedures 2) Individuals unable to comply with scheduled visits, assessments, or biospecimen collection 3) Individuals deemed clinically inappropriate for participation at the discretion of the investigator 4) Individuals who are unable to adequately understand the study during the consent process

Design outcomes

Primary

MeasureTime frame
Association between baseline respiratory and gut microbiome profiles and short-chain fatty acids (SCFAs) with 12-month change in forced vital capacity (FVC)—

Secondary

MeasureTime frame
Association between baseline microbiome/SCFA profiles and 12-month change in diffusing capacity (DLCO);Association between microbiome/SCFA profiles and longitudinal changes in six-minute walk distance (6MWD);Association of baseline microbiome and SCFA features with clinical events including acute exacerbation, hospitalization, and mortality—

Countries

Korea, Republic of

Contacts

Public ContactHee-Young Yoon

Soon Chun Hyang University Hospital Seoul

bluecat-s@hanmail.net+82-2-710-3507

Outcome results

None listed

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