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IRCT2015030421338N1 IRCT 2015-04-11 Isfahan University of Medical Sciences Effects of Probiotics on diarrhea Effects of Probiotics for the Prevention and Treatment of Radiation-induced Diarrhea in Patients with Cancer 2012-09-22 anticipated 63 Complete https://irct.ir/trial/18725 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A Neoplasms. Intervention 1: group two take a combination of probiotic and honey (two probiotic capsules and 30 grams honey per day, one capsule and 15 grams honey in the morning after breakfast and another one capsule in the evening, and 15 grams honey at night). Intervention 2: group three are the control group receive two placebo capsules (containing 500 mg of corn starch) per day, one capsule in the morning after breakfast and another one in the evening. Intervention 3: group one take probiotics )contained: Lactobacillus casei 1.5 × 109 CFU, Lactobacillus acidophilus 1.5 × 1010 CFU, Lactobacillus rhamnosus 3.5 × 109 CFU, Lactobacillus bulgaricus 2.5 × 108 CFU, Bifidobacterium breve 1 × 1010 CFU, Bifidobacterium longum 5 × 108 CFU and Streptococcus thermophilus 1.5 × 108 CFU per 500 mg(; two probiotic capsules per day, one capsule in the morning after breakfast and another one in the evening.
public Hajar-Alsadat Mansouri-Tehrani
Hezar Jarib Street
Isfahan Iran (Islamic Republic of) +98 31 3273 2059 hajar_mansouri@yahoo.com University of Isfahan scientific Dr. Mahnaz Roayaei
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) +98 31 3776 7396 Roayaei@med.mui.ac.ir Isfahan University of Medical Sciences Iran (Islamic Republic of) The inclusion criteria: Patients with pelvic cancers (colorectal, prostate, endometrial, bladder, ovary, cervical, bone sarcoma) who undergo pelvic radiotherapy. The exclusion criteria: The presence of any acute or chronic gastrointestinal condition associated with diarrhea before recruitment and getting pelvic radiotherapy in the past. 18 years 85 years Both C17, C18, Malignant neoplasm of small intestine, Malignant neoplasm of colon, Malignant neoplasm of rectosigmoid junction, Malignant neoplasm of rectum Treatment - Drugs Treatment - Drugs Treatment - Drugs group two take a combination of probiotic and honey (two probiotic capsules and 30 grams honey per day, one capsule and 15 grams honey in the morning after breakfast and another one capsule in the evening, and 15 grams honey at night) group three are the control group receive two placebo capsules (containing 500 mg of corn starch) per day, one capsule in the morning after breakfast and another one in the evening group one take probiotics )contained: Lactobacillus casei 1.5 × 109 CFU, Lactobacillus acidophilus 1.5 × 1010 CFU, Lactobacillus rhamnosus 3.5 × 109 CFU, Lactobacillus bulgaricus 2.5 × 108 CFU, Bifidobacterium breve 1 × 1010 CFU, Bifidobacterium longum 5 × 108 CFU and Streptococcus thermophilus 1.5 × 108 CFU per 500 mg(; two probiotic capsules per day, one capsule in the morning after breakfast and another one in the evening Diarrhea grade. Timepoint: Weekly from one week before radiotherapy until end of treatment. Method of measurement: Common Toxicity Criteria system. Stool consistency score. Timepoint: Weekly from one week before radiotherapy until end of treatment. Method of measurement: Bristol scales. Blood cell counts. Timepoint: Weekly from one week before radiotherapy until end of treatment. Method of measurement: cell counter machine. Serum IgA level. Timepoint: Weekly from one week before radiotherapy until end of treatment. Method of measurement: Autoanalyzer machine. Bloting. Timepoint: Weekly during treatment. Method of measurement: Question from the patient. Isfahan University of Medical Sciences Approved 2012-10-17 Center of Medical Research - Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran Isfahan Iran (Islamic Republic of)