RadItion Proctitis
Conditions
Interventions
Dose Group 1:Oral administration of Tpselacrhabac with a content of 1 × 10 ^ 7cfu, 3 times a day
Dose Group 2:Oral administration of Tpselacrhabac with a content of 1 × 10 ^ 8 cfu, 3 times a day
Dose Group 3:Oral administration of Tpselacrhabac with a content of 1 × 10 ^ 9 cfu, 3 times a day
Phase II Group:Oral R2PD dosage Tpselacrhabac
Sponsors
The First Affiliated Hospital of Xinxiang Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate, sign the informed consent form, and have good compliance, and be able to cooperate with diagnosis and treatment and follow-up; Age> = 18 years old (inclusive), male or female; 2. Patients with pelvic malignant tumors diagnosed by pathological histology or cytology, pelvic radiotherapy, and clinically diagnosed as grade 1-2 (CTCAE) radiation proctitis; 3. KPS score>=60 points; 4. Estimated survival >=6 months; 5. The function of the main organs is basically normal, and the laboratory examination meets the following standards: (1) Hematology 1) Absolute neutrophil count>=1.5×10^9/L; 2) Platelet >=75×10^9/L; 3) hemoglobin >=90g/L; (2) Kidneys 1) creatinine clearance (CrCl) or estimated glomerular filtration rate (eGFR) >60ml/min/1.73m^2 (Cockcroft-Gault formula); (3) Liver 1) Serum total bilirubin =30g/L (4) Coagulation function 1) International normalized ratio (INR) or prothrombin time (PT) < 1.5 × ULN, if the subject is receiving anticoagulant therapy, as long as the PT is within the intended range of anticoagulant use.
Exclusion criteria
Exclusion criteria: 1. Severe internal and external rectal hemorrhoids; 2. Allergy to any component of the test drug; 3. Combined with inflammatory bowel disease, irritable bowel syndrome, chronic gastrointestinal bleeding and other diseases that may be accompanied by chronic diarrhea symptoms; 4. Special dietary preferences that predispose to intestinal symptoms and cannot be corrected. 5. Those who have personality or mental disorders, have no civil behavior or limited capacity for civil conduct; 6. There is a medical history or disease, treatment or laboratory abnormality that may interfere with the results of the trial and prevent the subject from participating in the study throughout the whole process, 7. Other situations that are considered by the investigator to be unsuitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events;Rate of remission of clinical symptoms of radiation proctitis;Improvement of rectal mucosal lesions under colonoscopy; | — |
Countries
China
Contacts
Public ContactZhihong Mei; Ping Lu
The First Affiliated Hospital of Xinxiang Medical University
Outcome results
None listed