Predicting sepsis outcomes using nasal and gut microbiota
Nasal and Gut Microbiota Combined Clinical Events Predicts the Prognosis of Patients With Sepsis: a Prospective, Multicentered, Diagnostic Trial
This study is testing whether analyzing the bacteria in the nose and gut of sepsis patients can help predict how well they will do in recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Zhujiang Hospital Academic / other |
| Locations | 2 sites (Dongguan, Guangdong and 1 other locations) |
| Trial ID | NCT05143736 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze nasal and fecal specimens from patients diagnosed with sepsis in critical care units. By collecting samples at enrollment and on subsequent days, researchers will extract and sequence DNA to characterize the microbiota. The goal is to develop a predictive model that combines microbiota characteristics with clinical data to forecast patient prognosis and the progression of sepsis. This approach seeks to enhance understanding of the relationship between microbiota and sepsis outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 who meet the diagnostic criteria for sepsis and have elevated serum procalcitonin levels.
Not a fit: Patients with conditions such as advanced tumors, severe immunodeficiency, or those under limited care may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prognostic tools for sepsis, enabling better patient management and outcomes.
How similar studies have performed: While the relationship between microbiota and sepsis is being explored, this specific predictive model approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Meet the 2016 International Sepsis Guidelines diagnostic criteria (sepsis 3.0). 2. Serum procalcitonin≥ 2 ng/mL at enrollment. Exclusion Criteria: Patients will be excluded if participants meet any of the following criteria: 1. age\<18 years old or \> 80 years 2. pregnancy or lactation 3. solid organ or bone marrow transplant 4. advanced pulmonary fibrosis 5. HIV-positive 6. neutropenia; 7. hematological/lymphatic tumors have no remission; 8. limited care (lack of commitment to full and aggressive support); 9. long-term use of immunosuppressive drugs or immunodeficiency; 10. advanced tumors; 11. combined with noninfectious factors leading to death (uncontrolled large bleeding, cerebral hernia, etc.); 12. Combined with autoimmune diseases 13. Paraquat poisoning 14. Combined with Nasopharyngeal carcinoma 15. Combined with chronic nasosinusitis 16. Combined with severe nasal injuries
Where this trial is running
Dongguan, Guangdong and 1 other locations
- Department of Critical Care Medicine of Dongguan People's Hospital, Dongguan — Dongguan, Guangdong, China (Recruiting)
- Department of Critical Care Medicine of Zhujiang Hospital — Guanzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Zhanguo Liu, M.D.PhD — Department of Critical Care Medicine of Zhujiang Hospital
- Study coordinator: Zhanguo Liu, M.D.PhD
- Email: zhguoliu@163.com
- Phone: +86-2062782927
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.