Radiation Enteritis
Conditions
Interventions
Auto-FMT group:Fecal samples of subjects will be collected by the research team one week before radiotherapy. After passing the 16S rRNA detection, the bacterial solution will be collected and prepare
Control group:Auto-FMT will not be performed, and conventional symptomatic treatment will be given. In case of diarrhea, commercial Clostridium butyricum dual viable bacteria capsules will be administ
Sponsors
Shanghai First Maternity and Infant Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in the study with good compliance, able to cooperate with trial observations, and sign a written informed consent form; 2. Diagnosed with cervical cancer by pathology, imaging, laboratory tests (including biochemistry and tumor markers), with no previous history of radiotherapy; 3. Patients scheduled to receive radical radiotherapy for cervical cancer; 4. Subjects with an expected survival of more than 24 months; 5. Aged >=18 years; 6. Good heart, lung, liver, and kidney function, with no contraindications to radiotherapy or chemotherapy; 7. Negative for hepatitis virus, HIV, and syphilis; 8. Fecal tests: normal routine fecal examination and negative occult blood test; 9. No gastrointestinal discomfort in the past 2 weeks; no use of antibiotics, acid suppressants, immunosuppressants, chemotherapeutic drugs, or history of blood transfusion in the past 3 months; 10. No chronic pain symptoms, no history of digestive system surgery, no history of infectious diseases or contact with infectious diseases, and no history of allergic diseases, autoimmune diseases, metabolic diseases, neurological or psychiatric diseases; 11. No habits of smoking, drinking, or drug abuse, no drug addiction; no vaccination or participation in drug trials in the past 6 months; no travel history to tropical regions in the past 6 months; 12. No family history of gastrointestinal lesions, no family history of malignant tumors, and no family history of infectious diseases.
Exclusion criteria
Exclusion criteria: 1. Patients who are unable or unwilling to receive fecal microbiota transplantation; 2. Patients with other diseases or complications such as acute or chronic infectious diseases, digestive tract diseases, severe cardiac insufficiency, severe liver or renal insufficiency; 3. Pregnant or lactating women; 4. Patients with a history of severe colitis or inflammatory bowel disease (IBD) of any etiology; 5. Patients whose feces collected for post-radiotherapy transplantation show low biodiversity (IS index < 2.0) or positive results in intestinal pathogen detection (e.g., Clostridium difficile, Campylobacter, Salmonella, Shigella, Shiga toxin-producing Escherichia coli, as well as eggs, cysts, parasites, Cronobacter sakazakii, Yersinia enterocolitica, pathogenic Vibrio, Aeromonas, Entamoeba, spores, norovirus, rotavirus, etc.); patients positive for multidrug resistance genes (extended-spectrum ß-lactamases, carbapenemases, vancomycin resistance, etc.), or positive for fecal Helicobacter pylori antigen; 6. Patients receiving long-term antibiotic therapy to prevent or suppress persistent infections, involving antibiotics that disrupt intestinal flora; 7. Patients with allergic diathesis; 8. Patients with newly developed cardiovascular or cerebrovascular diseases within the past three months; 9. Patients with coagulation dysfunction or immune system abnormalities; 10. Patients who received any of the following treatments within 30 days prior to enrollment: oral antibiotics, antiviral drugs, antifungal drugs, preservatives, systemic immunosuppressive or immunomodulatory drugs, oral or topical probiotics; 11. Patients who took probiotic preparations within 30 days prior to enrollment; 12. Patients concurrently participating in other clinical trials; 13. Patients with any clinically significant disease history or disorder (ascertained by inquiry) that, in the investigator’s judgment, may put them at risk by participating in the study, affect the results, or impair their ability to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of acute radiation enteritis;Efficacy evaluation of radiotherapy for cervical cancer; | — |
Secondary
| Measure | Time frame |
|---|---|
| RTOG/EORTC score for intestinal reactions after radiotherapy;Gastrointestinal Qality of Life Index (GIQLI);Nutritional status; | — |
Countries
China
Contacts
Public ContactYingchao Liang
Shanghai First Maternity and Infant Hospital
Outcome results
None listed