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Evaluation of the potential efficacy and safety of fecal microbiota transplantation in patients with sepsis: A multicenter, prospective study

Evaluation of the potential efficacy and safety of fecal microbiota transplantation in patients with sepsis: A multicenter, prospective study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113131
Enrollment
Unknown
Registered
2025-11-25
Start date
2025-11-30
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

Sepsis

Interventions

Control group:After conventional therapy (targeted antimicrobial therapy directed against the pathogen identified by microbiological testing), no further intervention is given.

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age >=18 years and =2); 3. The study participant or their guardian can fully understand the content of the informed consent for this trial and voluntarily sign the informed consent form; 4. Able to attend follow-up visits, undergo follow-up examinations, and provide specimens, including blood and stool samples on time.

Exclusion criteria

Exclusion criteria: 1. Patients in a moribund state or who die within 48 hours of enrollment; 2. Patients who have participated in other drug studies within the past 3 months; 3. Patients who have received FMT treatment in the past 12 months; patients during pregnancy and postpartum; patients with immune abnormalities; 4. Patients who have used probiotics, prebiotics, antibiotics, or other medications that may affect the gut microbiota within 3 months prior to treatment, or who plan to use such medications in the following 4 months; 5. Patients previously diagnosed with organic gastrointestinal diseases or severe gastrointestinal issues requiring immediate treatment, such as congenital megacolon, intestinal perforation, gastrointestinal bleeding, intestinal obstruction, intussusception, inflammatory bowel disease, celiac disease, perianal infections, or patients with a stoma; 6. Patients with other serious diseases that could affect the evaluation of this study, such as severe liver disease, severe immunodeficiency, heart disease, cerebrovascular disease, kidney disease, malignancy, and alcoholism; 7. Other patients deemed unsuitable for enrollment by the investigator.

Design outcomes

Primary

MeasureTime frame
Sequential Organ Failure Assessment;Length of ICU stay;28-day mortality rate;

Secondary

MeasureTime frame
Immunological indicators;Metabolite characteristics;Proteomic characteristics;The changes in the richness of the intestinal flora after treatment;Procalcitonin;

Countries

China

Contacts

Public ContactLi Jiabin

The First Affiliated Hospital of Anhui Medical University

lijiabin@ahmu.edu.cn+86 159 0819 5595

Outcome results

None listed

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