chemotherapy and targeted therapy related diarrhea
Conditions
Interventions
Standard Dose Group:Taking Selenium-enriched Bifidobacterium longum DD98
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. patients patients or family members can understand the study protocol and are willing to participate in the study, signed informed consent; 2. patients >= 18 years old; 3. patients diagnosed with malignant tumours and are receiving anti-tumor drug treatment. Patients with malignant tumours undergoing anti-tumour therapy, including chemotherapy and targeted therapy; 4. Patients with chemotherapy-induced diarrhea, which meets the diagnostic and grading criteria of Chemotherapy-Induced Diarrhea (Chemotherapy-Induced Diarrhea) of the International Society Against Cancer (ISCA) and is 3 months.
Exclusion criteria
Exclusion criteria: 1. Patients who have suffered from diarrhoea due to non-antitumoural drugs prior to enrolment and have not fully recovered by 4 weeks prior to baseline; 2. Patients who are on antidiarrhoeal medication, non-steroidal anti-inflammatory medication, antibiotics, selenium supplementation products, or probiotics and are not able to discontinue the medication 7 days prior to baseline; 3. Patients who are suffering from any type of condition leading to chronic diarrhoea, including, but not limited to, inflammatory bowel disease (e.g., ulcerative colitis and Crohn's disease), chronic diarrhoea of infectious origin, and irritable bowel syndrome; (subject to necessary blood and faecal tests for exclusion) 4. The patient is suffering from other uncontrolled medical conditions, including, but not limited to, persistent or active infections, symptomatic congestive heart failure, unstable angina pectoris, recent cardiac infarction, uncontrolled hypertension or hypotension, cardiac tachyarrhythmia, or psychosocial disorders, as well as other social and psychological disorders that might social conditions that limit patient compliance with study requirements; 5. The patient has significant laboratory abnormalities: e.g., liver function, ALT/AST/ALP >2 ULN or/and GGT >3 ULN; renal function or haematopoietic-related abnormalities. Any other disease, clinically significant metabolic abnormality, physical examination abnormality, or laboratory abnormality that, in the investigator's judgement, justifies the suspicion that the patient has a disease or condition (e.g., epileptic seizures requiring treatment) that is inappropriate for the use of functional foods, or that would interfere with the interpretation of the results of the study or place the patient at a high level of risk. 6. The patient is a pregnant or breastfeeding woman; 7. The patient is a woman of childbearing potential who is not willing to use effective contraception two weeks before, during and three months after the trial; 8. The patient is a man of childbearing potential who is not willing to use effective contraception to avoid pregnancy in his partner two weeks before, during and three months after the trial; 9. The patient is unable to take the experimental functional food orally; 10. The patient has participated in another clinical study of a drug or medical device within the previous 3 months or is planning to participate in another clinical study during the study period; 11. Allergy to the ingredients in the experimental functional food; 12. Any other conditions that, in the judgement of the investigator, make participation in the study unsuitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relief of diarrhoea after 2 weeks of product administration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dose reduction of antitumour therapy due to diarrhoea;Number of hospitalisations for diarrhoea;Whether intravenous rehydration is required;Degree of relief of diarrhoea after 1, 4 and 8 weeks of product administration; | — |
Countries
China
Contacts
Public ContactYu Yiyi
Zhongshan Hospital, Fudan University
Outcome results
None listed