The Effects of probiotic supplementation on related side effects after chemotherapy and laboratory symptoms in metastatic gastrointestinal cancer patients:A randomized control trial

Description and comparison of primary and clinical information of patients with metastatic GI cancer between the two case and control groups

The clinical trial of Bayini has a randomized control group without blinding in phase 3 on 160 patients based on the Ralloc package.

Due to the fact that the doctor, researchers and the patient know about the type of intervention received, the study is designed as an open label (non-blinding).

Inclusion criteria: 18-65 years old with metastatic GI cancer who are undergoing chemotherapy Not having lactose intolerance No symptoms of diarrhea, constipation, nausea and vomiting, mucositis before receiving chemotherapy The operation status is 0 or 1 according to ECOG (Eastern and has Cooperative Oncology Group) Exclusion criteria: unwillingness to participate in the study, History of IBD Previous history of colectomy Use of any antibiotic or other drugs

Patients who take 500 mg Femilact probiotic capsules from the bio-fermenting company twice a day before breakfast and dinner for one week, which contains casei, lactobacillus lactobacillus acidophilus, lactobacillus rhamnosus, lactobacillus bulgaricus, bifidobacterium breve, bifidobacterium longum, streptococcus thermophiles, and fructooligosaccharides

Side effects, including frequency, severity of diarrhea and vomiting, mucositis, constipation after each course of chemotherapy for up to three months, as well as laboratory criteria, including CEA, CA19. 9 and inflammatory factors such as diff, IL 6- ESR, CRP, ferritin, pct, fibrinogen, CBC will be checked before and after receiving probiotics for 3 and 6 months

All people eligible to enter the study will be randomly assigned to one of the two groups to receive probiotics and placebo with a ratio of 1:1. The randomization method will be block permuted randomization, based on the sample size, the blocks will be divided into 26 blocks of sizes two, four, six, eight, and ten to complete the sample size using the "Ralloc" package in the STATA software. Patients will be included in each group based on the determined sample size and the list of random individuals (along with a special research code for each individual).

All patient information will be entered into the database (Excel file) after collecting it in a paper checklist, and after checking the range of data in terms of the presence of outliers and cleaning it (data cleaning), it will be prepared for statistical analysis. The final data file will be provided to the research department of internal diseases department to conduct further studies.

6 months after publishing data

Academic Researchers

If there is a positive conclusion from the research and the need for further studies

Dr Niusha Nosrati, Internal Medicine Clinic, Imam Hossein Hospital

Through the written request of the applicant to the research department of the hospital