Transplanting healthy gut bacteria to treat severe infections in critically ill patients
Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections:A Randomized Clinical Trial
This study tests whether giving healthy gut bacteria to critically ill patients with severe infections can help them recover better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | Shanghai 10th People's Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05578196 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of fecal microbial transplantation (FMT) to treat critically ill patients suffering from severe infections. The approach involves transferring functional microbiota from healthy donors into the gastrointestinal tract of patients to restore their intestinal flora and enhance immune response. Patients will receive a daily injection of a prepared fecal bacteria solution for six consecutive days, alongside standard treatment measures. The goal is to evaluate the effectiveness of FMT in improving outcomes for patients with severe infections.
Who should consider this trial
Good fit: Ideal candidates include patients aged 14 and older diagnosed with severe infections and meeting specific clinical criteria.
Not a fit: Patients with advanced tumors, systemic immunosuppression, severe intestinal conditions, or those unable to undergo the treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery rates and outcomes for patients with severe infections.
How similar studies have performed: While fecal microbial transplantation has shown promise in other contexts, this specific application in critically ill patients with severe infections is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed with severe infections, which is infected patients SAFA≥2 OR APACHE Ⅱ≥15 * Aged ≥14 years * Patients or their family members agreed to participate in this study Exclusion Criteria: * Advanced tumors or diseases associated with systemic immunosuppression * Pregnant women * Patients with severe intestinal ulcer or perforation * Unable to complete oral administration and no effective artificial feeding pipeline.
Where this trial is running
Shanghai
- Shanghai Tenth Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: YuanZhuo Chen
- Email: chenyuanzhuo@tongji.edu.cn
- Phone: 13764528213
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.