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Exploring the Application Value and Underlying Mechanism of Fecal Microbiota Transplantation in Early Acute Gastrointestinal Injury Following Cardiopulmonary Bypass Surgery

Exploring the Application Value and Underlying Mechanism of Fecal Microbiota Transplantation in Early Acute Gastrointestinal Injury Following Cardiopulmonary Bypass Surgery

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087555
Enrollment
Unknown
Registered
2024-07-30
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-08-05

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

Conditions

Acute gastrointestinal injury in the early stage after cardiopulmonary bypass

Interventions

Experimental group :Fecal microbiota transplantation
Control group:Compound lactic acid bacteria capsule

Sponsors

The First Hospital of Lanzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Patients who develop acute gastrointestinal injury within one week after undergoing cardiopulmonary bypass heart surgery, and are diagnosed with AGI levels II-IV. 2.Patients age range is from 18 to 70. 3.Study participants and their families should be informed about the study and sign consent forms.

Exclusion criteria

Exclusion criteria: 1. Patients with perioperative gastrointestinal hemorrhage; 2..Patients who are using strong antibiotics such as third-generation cephalosporins or carbapenems alone, or any combination of two or more antibiotics; 3. Patients with a history of chronic gastrointestinal disease or gastrointestinal surgery; 4. Patients were diagnosed with systemic diseases before surgery, such as malignant tumor, metabolic syndrome, connective tissue disease, congenital or acquired immune deficiency disease, etc. 5.Patients had severe organ dysfunction before surgery, such as heart, lung, liver, and kidney failure, etc; 6. Patients has a history of chemotherapy and radiation therapy; 7. Pregnant and lactating women; 8. The subjects and their families did not sign the informed consent.

Design outcomes

Primary

MeasureTime frame
The incidence of improved gastrointestinal function in patients one week after intervention;AGI Diagnosis Classification;

Secondary

MeasureTime frame
16S rRNA sequencing results of intestinal flora of patients before and after intervention;Intestinal flora metabolites of patients before and after FMT intervention;DAO;D-Lactate;IL-6;IL-1ß;Immunoglobulin;T-cell subsets;Sequential Organ Failure Assessment;Length of Stay;Duration of Mechanical Ventilation;Duration of Mechanical Ventilation;Incidence of Adverse Events;Mortality rate;CRP;

Countries

China

Contacts

Public ContactWenjun Zhou/ Jian Liu

The First Clinical Medical College of Lanzhou University;Gansu Provincial Maternity and Child Health Hospital/Gansu Provincial General Hospital,

medecinliujian@163.com+86 136 0935 4197

Outcome results

None listed

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