Tumors of the digestive system
Conditions
Interventions
Control Group:Chemotherapy/Targeted Therapy
Experimental Group:Chemotherapy/Targeted Therapy+FMT
Sponsors
The Second Affiliated Hospital Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age>= 18 years, any gender; 2. Estimated survival >=3 months; 3. Pathologically confirmed gastrointestinal tumors, including esophageal cancer, gastric cancer, colon cancer, rectal cancer, etc.; 4. Cancer TNM stage IV; 5. PD-1 or PD-L1 testing has been conducted; 6. Planning to undergo the fourth cycle of chemotherapy/targeted therapy; 7. Gastrointestinal adverse reactions occurred during the first three cycles of routine chemotherapy/targeted therapy (including but not limited to diarrhea, constipation, nausea, and vomiting); 8. The patient is able and willing to sign the informed consent form and complete follow-up; 9. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 1–3; 10. Use of oral/IV broad-spectrum antibiotics should be cautious within 3 days; 11. The patient is able to swallow capsules without chewing; 12. Screening period laboratory results indicate the subject has sufficient organ function.
Exclusion criteria
Exclusion criteria: 1.Patients with major organ dysfunction or even failure, including but not limited to cardiac insufficiency or heart failure, renal insufficiency or renal failure, and hepatic insufficiency/hepatic failure; 2.Uncontrolled or severe infections; 3.Known history of psychotropic substance abuse, alcoholism, and drug abuse; 4.Patients with severe infections complicated with septicemia or sepsis; 5.Patients with a history of severe allergic reactions or a known allergy to the components of liquid live bacteria enteric-coated capsules; 6.Patients with active viral infections; 7.Female subjects with a positive pregnancy test, lactating female subjects, and women of childbearing age who refuse to use contraceptive measures during the entire observation period (15 weeks); 8.Patients with gastrointestinal perforation and/or fistula; 9.Other conditions deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Structure and distribution of gut microbiota; | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory indicators:Liver and kidney function; routine blood, urine, and stool tests.Neutrophil Ratio (NE Ratio).Hemoglobin (Hb).White Blood Cell (WBC).Differential White Blood Cell Count.Platelet (PLT).Lymphocyte Count.;Mental Status ;Adverse events and serious adverse events;Bristol Stool Scale Score;Gastrointestinal symptoms;Quality of Life Score;Number of bowel movements (times/day).;Nutritional Status Assessment; | — |
Countries
China
Contacts
Public ContactDa Wang
The Second Affiliated Hospital Zhejiang University School of Medicine
Outcome results
None listed