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IRCT20240629062278N1 IRCT 2024-07-03 Shahid Beheshti University of Medical Sciences he Effects of probiotic supplementation on related side effects after chemotherapy laboratory symptoms and in metastatic gastrointestinal cancer The Effects of probiotic supplementation on related side effects after chemotherapy and laboratory symptoms in metastatic gastrointestinal cancer patients:A randomized control trial 2024-07-05 anticipated 160 Complete https://irct.ir/trial/77676 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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). 3 GI Metastatic Cancer. Intervention 1: Intervention group: Take one probiotic capsule (500 mg) containing casei, lactobacillus acidophilus, lactobacillus rhamnosus, lactobacillus bulgaricus, bifidobacterium breve, bifidobacterium longum, streptococcus thermophiles and prebiotic a as fructooligosaccharides before breakfast and dinner twice a day and It is up to one week after starting the treatment. Intervention 2: Control group: Under the title of control group without receiving placebo control (no-treatment)(group. Yes - There is a plan to make this available What will be shared: 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. When: 6 months after publishing data To whom: Academic Researchers Conditions: If there is a positive conclusion from the research and the need for further studies Where to obtain: Dr Niusha Nosrati, Internal Medicine Clinic, Imam Hossein Hospital How to obtain: Through the written request of the applicant to the research department of the hospital Comments:
public Niusha Nosrati
Madani Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 niushanosrati72@gmail.com Shahid Beheshti University of Medical Sciences scientific Farnaz Saberian
Madani Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 dr.f.saberian@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 65-18 years old with metastatic GI cancer undergoing chemotherapy No lactose intolerance Did not have any symptoms of diarrhea, constipation, nausea, vomiting, or mucositis before receiving chemotherapy, Functional status 0 or 1 according to ECOG (Eastern Cooperative Oncology Group) 18 years 65 years Both Reluctance of the patient to participate in the study Description of underlying diseases including IBD \History of Colectomy Taking any antibiotic or other drugs Z85 Personal history of malignant neoplasm Treatment - Drugs Other Intervention group: Take one probiotic capsule (500 mg) containing casei, lactobacillus acidophilus, lactobacillus rhamnosus, lactobacillus bulgaricus, bifidobacterium breve, bifidobacterium longum, streptococcus thermophiles and prebiotic a as fructooligosaccharides before breakfast and dinner twice a day and It is up to one week after starting the treatment. Control group: Under the title of control group without receiving placebo control (no-treatment)(group Examination of gastrointestinal symptoms: examination of changes in the severity of symptoms up to three chemotherapy courses (equivalent to 3 months) compared to zero time. Timepoint: Zero time & 3 months later. Method of measurement: The severity of diarrhea is described using the CTCAE Common Terms for Adverse Events criteria (NCI, National Cancer Institute). The severity of mucositis according to the CTCAE criteria.The type and severity of constipation based on the criteria (BRISTOL BSFS). Examining inflammatory factors and tumor markers: Examining the changes three and six months after the intervention compared to zero time. Timepoint: Zero time, 3 and 6 months later. Method of measurement: laboratory evaluation. Shahid Beheshti University of Medical Sciences Approved 2024-06-18 Ethics Committee, Faculty of Medicine, Shahid Beheshti University of Medical Science Shahid Beheshti University of Medical Science, Arabi Ave, Daneshjoo Blv, Velenjak, Tehran Tehran Tehran Iran (Islamic Republic of)