Efficacy of Fecal Microbiota Transplantation in Treating Gastrointestinal Dysfunction in Critically Ill Patients: A Single-Center Prospective Study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500100989

Enrollment

Unknown

Registered

2025-04-17

Start date

2025-05-01

Completion date

Unknown

Last updated

2025-04-21

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

Conditions

Acute Gastrointestinal Injury

Interventions

Control group:Conventional treatment comprising: Management of intra-abdominal hypertension (IAH) Administration of prokinetic agents (e.g., domperidone, metoclopramide, erythromycin)

FMT group:Fecal microbiota transplantation (FMT) plus conventional therapy group

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18-75 years (inclusive), regardless of gender; 2. ICU stay: Expected ICU length of stay >=7 days; 3. Organ dysfunction: SOFA (Sequential Organ Failure Assessment) score >=2 points; 4. Gastrointestinal injury: AGI (Acute Gastrointestinal Injury) grade II or III; 5. Informed consent: Patient or legally authorized representative fully understands the study protocol and voluntarily signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity to any component of the investigational drug(s); 2. Postoperative patients admitted to ICU following gastrointestinal surgery; 3. Intra-abdominal hypertension (IAH) with intra-abdominal pressure (IAP) >20 mmHg; 4. Active gastrointestinal disorders: Massive hemorrhage, Perforation, Intestinal obstruction; 5. Diagnosed inflammatory bowel diseases: Ischemic colitis, Fulminant colitis, Toxic megacolon; 6. Congenital or acquired immunodeficiency disorders (e.g., HIV/AIDS, SCID); 7. Use of cytotoxic agents within 3 months prior to enrollment (e.g., rituximab, cyclophosphamide, methotrexate); 8. Prolonged corticosteroid use (>20 mg prednisone equivalent/day for >=4 weeks); 9. Severe immunosuppression: Absolute neutrophil count (ANC) <0.5×10^9/L; 10. Concurrent participation in other clinical trials with potential interference to outcome assessment.

Design outcomes

Primary

Measure	Time frame
Gastrointestinal function improvement rate;	—

Secondary

Measure	Time frame
Gut microbiota composition and a diversity; ICU length of stay (ICU LOS);Total length of hospital stay;Ventilator Days;Total Cost of ICU Stay;Clinical Outcomes;	—

Countries

China

Contacts

Public ContactShao Min

The First Affiliated Hospital of Anhui Medical University

shaomin@ahmu.edu.cn+86 156 5606 5677

Outcome results

None listed

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