Chemotherapy induced diarrhea
Conditions
Interventions
Experimental group:Five-strain Probiotic Capsules
Control group:Placebo
Sponsors
The Sixth People’s Hospital of Chengdu,
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Voluntarily sign the informed consent form and be able to comply with the protocol requirements; 2.Aged 18 to 70 years at the time of informed consent; 3.Diagnosed with malignant tumors and scheduled to receive chemotherapy regimens containing fluorouracil/irinotecan; 4.Expected survival time of more than 6 months at screening.
Exclusion criteria
Exclusion criteria: 1. Presence of other diarrhea-related diseases at screening, such as Crohn's disease, irritable bowel syndrome, antibiotic-associated diarrhea, or acute/chronic gastrointestinal infections; 2. Presence of intestinal obstruction or immunodeficiency (e.g., HIV infection) at screening; 3. Uncontrolled concurrent illnesses at screening, including but not limited to persistent or active infections; 4.Patients with gastrointestinal stomas or receiving total parenteral nutrition; 5.History of severe hypersensitivity (immediate, life-threatening systemic allergic reactions) to similar drugs (e.g., Zhengchangsheng, Siliankang) or any excipients (e.g., corn starch); 6.Current use of probiotics or systemic antibiotics at screening; 7.Any other condition that, in the investigator’s judgment, may interfere with the assessment of safety or efficacy in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of grade 3-4 diarrhea during the trial; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bristol Stool Scale (BSS) ?bowel movement frequency ?Time from diarrhea onset to loperamide rescue treatment?Time of onset and duration of chemotherapy-induced diarrhea, abdominal symptom scores,;Safety Evaluation; | — |
Countries
China
Contacts
Public ContactYe Bin
The Sixth People’s Hospital of Chengdu,
Outcome results
None listed