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IRCT20210704051788N1 IRCT 2021-10-10 Shiraz University of Medical Sciences Study of the potential radioprotective effects of probiotic bacteria to mitigate gastrointestinal complications after conventional radiotherapy Study of the potential radioprotective effects of probiotic bacteria to mitigate gastrointestinal complications of colorectal cancer after conventional radiotherapy 2021-10-12 anticipated 60 Complete https://irct.ir/trial/58898 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Participants will take probiotics for up to ten days after completing radiotherapy, Randomization description: Participants are randomly assigned to three groups to receive probiotics one week before the start of radiotherapy (n = 20), one week after the start of radiotherapy (n = 20) or placebo (n = 20), Blinding description: Randomization will be hidden from researchers and participants until the statistical analysis is completed.Another person who has no role in this clinical trial and is not aware of random allocation gives the capsules to participants. 3 Condition 1: Colorectal Cancer. Condition 2: Colorectal Cancer. Intervention 1: Intervention group: 1-Patients will take two capsules (daily) containing several probiotic strains from one week before the start of treatment until 10 days after the end of radiotherapy. Intervention 2: Intervention group: 2-Patients will take two capsules (daily) containing several probiotic strains from one week after the start of treatment to 10 days after the end of radiotherapy. Intervention 3: Control group: Two placebo capsules daily for ten days after the end of radiotherapy. Yes - There is a plan to make this available What will be shared: All data can be shared without personal information When: 6 months after the publication of the results will be given access To whom: It will be available to researchers working in academic and scientific institutions Conditions: All requests will be reviewed by the person in charge of public responses Where to obtain: All applicants should send their request to jamalihamidreza91@yahoo.com How to obtain: Requests will be processed within two weeks and the response will be emailed to the applicant. Comments:
public Hamidreza Jamali
Department of Medical Physics,7th floor, School of Medicine,Zand Blvd.
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3234 9332 jamalihamidreza91@yahoo.com Shiraz University of Medical Sciences scientific Dr. Seyed Mohammad Javad Mortazavi
Department of Medical Physics, 7th floor, School of Medicine, Zand Blvd.
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3208 3363 mortazavismj@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Adults with colorectal cancer who are candidates for radiotherapy as part of their treatment 18 years 90 years Both Consumption of narcotic painkillers Existence of acute and chronic gastrointestinal complications before starting treatment Take any antibiotics one week before the start to end of radiotherapy Received radiation therapy in the abdomen and pelvis in recent years Use probiotic supplements during the 15 days before the study and also take other probiotic forms including probiotic yogurt and other fermented foods C18 C20 Malignant neoplasm of colon Malignant neoplasm of rectum Treatment - Drugs Treatment - Drugs Placebo Intervention group: 1-Patients will take two capsules (daily) containing several probiotic strains from one week before the start of treatment until 10 days after the end of radiotherapy. Intervention group: 2-Patients will take two capsules (daily) containing several probiotic strains from one week after the start of treatment to 10 days after the end of radiotherapy. Control group: Two placebo capsules daily for ten days after the end of radiotherapy Quality of life. Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: Questionnaire. Gastrointestinal disorders. Timepoint: At the beginning of the study and 6 months after the intervention. Method of measurement: Clinical examination by an oncologist. Thrombocytopenia-Leukopenia-Anemia. Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: CBC Test(Complete blood count). Shiraz University of Medical Sciences Approved 2021-09-11 Ethics committee of Shiraz University of Medical Sciences Central building of Shiraz University of Medical Sciences -Zand Blvd Shiraz Fars Iran (Islamic Republic of)