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Gut microbiota transplantation affects the colonization of multiple drug-resistant bacteria in the gut of patients with severe infections: a multicenter, prospective study

Gut microbiota transplantation affects the colonization of multiple drug-resistant bacteria in the gut of patients with severe infections: a multicenter, prospective study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110363
Enrollment
Unknown
Registered
2025-10-13
Start date
2025-10-13
Completion date
Unknown
Last updated
2025-10-20

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

Conditions

severe infections

Interventions

Control group:No
Group 2:Fecal microbiota transplantation (FMT) treatment by transnasal jejunal tube
Group 3:Fecal microbiota transplantation (FMT) treatment by transendoscopic enteral tubing (TET)

Sponsors

Department of Infectious Diseases, First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Patients aged between 18 and 75 years old, regardless of gender; 2.Patients with a SOFA score between 2 and 5 who are eligible for nasojejunal or colonic catheterization; 3.Patients who have undergone anal swab screening on the day of admission or the next day and have intestinal colonization of multi - drug resistant bacteria (CRE, ESBL, MRSA, VRE); 4.Patients or their legal representatives who express their consent to participate in this clinical trial, abide by all research activities, sign a written informed consent form, and agree to receive intestinal microbiota transplantation and fecal sample collection.

Exclusion criteria

Exclusion criteria: 1.Known allergy to any component of the drugs involved in this study; 2.Patients admitted to the ICU after gastrointestinal surgery; 3.Patients with intra - abdominal hypertension (IAP > 20 mmHg); 4.Patients with massive gastrointestinal bleeding, gastrointestinal perforation, or intestinal obstruction; 5.Patients diagnosed with ischemic colitis, fulminant colitis, or toxic megacolon; 6.Patients with congenital or acquired immunodeficiency diseases; 7.Patients who have used cytotoxic drugs such as rituximab, cyclophosphamide, and methotrexate in the past 3 months; 8.Patients who have been continuously using medium - to high - dose steroid hormones for more than 4 weeks; 9.Severe immunosuppressed patients: such as those with a neutrophil count 5; 13.Patients who have previously had seizures caused by carbapenem drugs; 14.Patients who are currently participating in other clinical trials before enrollment; 15.Pregnant or breastfeeding patients; 16.Patients with a history of alcoholism or drug abuse or suffering from mental illness; 17.Situations where the researcher judges that the subject is not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
The decolonization rate of multi-drug resistant bacteria;

Secondary

MeasureTime frame
The changes in the richness of the intestinal flora after treatment;The decolonization rate of multi-drug resistant bacteria;

Countries

China

Contacts

Public ContactJiabin Li

The First Affiliated Hospital of Anhui Medical University

lijiabin@ahmu.edu.cn+86 551 6292 2713

Outcome results

None listed

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