Phase III

Summary:

In recent years, many researchers have investigated the biological and therapeutic effects of probiotics in preventing and treating some diseases such as cancer and gastrointestinal disorders. Since cytokines are biological messengersfor immune responses, they are considered as potential targets of induced mechanisms by probiotics. Current study is aimed to investigatethe effects Lactobacillus acidophilus as an adjuvant therapy with standard treatments, by improving the immune system functionin patients with rectal cancer. 150 patients who will refer to Firoozgar andImam Khomeini Hospital randomly from summer 95 to March 96. The patients will be simple randomly divided into two 75-patientgroups.The case group will receiveLactobacillus acidophilus capsule (1.5 g/daily, produced by ZistTakhmir Co), and the control group will receive the placebo capsulesfrom one day before chemo-radiation to one week before surgery for 13 weeks. At the beginning and the end of study, answering to the questionnaire and related forms (CRF, FFQ), height and weight measurement and blood sampling will be performed by an expert person.Furthermore, at the end of 13th week, CT Imaging will be done on the patient for reinvestigation of tumor size under the clinical diagnosis.The tests carried out on serum samples include ELISA technique for evaluating the serum levels of cytokines, Real-time PCR for measuring the expression of STAT4 gene, and Flowcytometry for CDs measurement.