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Evaluation the Association of Microbiome Between Respiratory Tract Samples and Stool Samples in Pneumonic Patients Accompanied by Respiratory Failure

Department of Critical Care Medicine, Taichung Veterans General Hospital

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03379779
Enrollment
200
Registered
2017-12-20
Start date
2017-08-28
Completion date
2019-09-01
Last updated
2019-09-16

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

Conditions

Lower Resp Tract Infection, Microbiota, Pneumonia, Bacterial, Respiratory Failure

Keywords

Microbiota, Respiratory Failure, Pneumonia, Lower Respiratory Tract Infection

Brief summary

A prospective observational study. Enrolled participants admitted to ICU due to pneumonia and respiratory failure need mechanical ventilator support. Investigators collected the residual specimens, such as sputum from endotrachea aspiration, bronchoalveolar lavage fluid in those participants as the usual care in the ICU. Those residual samples were sent to extract RNA and sequence by using high-throughput sequencing (next-generation sequencing) method. Investigators will compared the microbiome feature between lower respiratory tract and stool specimens in those participants diagnosed as pneumonia with respiratory failure.

Interventions

DIAGNOSTIC_TEST16s RNA sequence of sputum, bronchoalveolar lavage fluid (options), stool

We will check the microbiome in lower respiratory samples (sputum and bronchoalveolar lavage fluid) and stool by using 16S RNA sequencing

Sponsors

Taichung Veterans General Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adults aged than 40 years old * Diagnosed as pneumonia * Respiratory failure with mechanical ventilator support

Exclusion criteria

* Less than 40 years old * Has been treated with antibiotics more than 7 days within two weeks before enrolling into study * Suspected or active pulmonary tuberculosis infection

Design outcomes

Primary

MeasureTime frameDescription
The dynamics of the airway bacterial microbiome in the lower respiratory tract specimens in the setting of pneumonia accompanied by respiratory failure at the onset of, and day 3 and day 7 (or before extubation)Compared the dynamic change of mirobiome at the baseline (onset of respiratory failure within 48 hours)m day 3 and day 7Uses high-throughput sequencing (next-generation sequencing) to sequence the 16S rRNA sequence of bacteria in residual samples

Secondary

MeasureTime frameDescription
The dynamics of the gut bacterial microbiome in the stool specimens in the setting of pneumonia accompanied by respiratory failure at the onset of, and day 3 and day 7 (or before extubation)Compared the dynamic change of mirobiome at the baseline (onset of respiratory failure within 48 hours)m day 3 and day 7uses high-throughput sequencing (next-generation sequencing) to sequence the 16S
The association of the microbiome between lower respiratory tracts and stool specimens in pneumonic patient with respiratory failureCompared the association of mirobiome at the baseline (onset of respiratory failure within 48 hours)m day 3 and day 7Uses high-throughput sequencing (next-generation sequencing) to sequence the 16S

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026