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IRCT20210704051784N1 IRCT 2021-10-26 Tehran University of Medical Sciences Evaluation of the effect of probiotics in preventing low anterior resection syndrome Evaluation of the effect of probiotics in preventing lower rectal resection syndrome in patients with rectal cancer who have undergone lower anterior rectal resection 2021-11-21 anticipated 180 Complete https://irct.ir/trial/58027 interventional Randomization: N/A, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Blinding description: Patients who go under low anterior surgery and have ileostomy will randomly divided into 2 groups of 90. First, the patients will be explained how to do the job and 90 patients will be given probiotic pills daily and the other group will be given a placebo as a control group. Patients will be treated for 4 weeks. Block randomization method with a block size of 4 (marked with two As and two Bs randomly) will be used to randomize patients and assign them into two groups. Each A or B will be assigned to the specific number in the random number table. Only the treatment producing team including the specialist in pharmacology and the operator will be aware of the contents of each bottle (probiotic or placebo). The nursing team will attach the label of the bottles containing the random numbers. An experienced clinician will be responsible for doing the randomization in our study who generated the random allocation sequence and enrolled participants. Also, He/she will be responsible for the assignment of the participants to the intervention group. He/she will not have any role in participants’ treatment, analyzing the data, and writing the article of this trial and she is only responsible for blinding the study. N/A Patients with rectal cancer whose adenocarcinoma is pathologically proven and indicated for anterior resection.. Intervention 1: Intervention group: Multilateral probiotics in the form of LactoCare capsules made by Zist-Takhmir Company will be given to patients every 12 hours (after lunch and after dinner) for 4 weeks. Participants will be given the necessary training before conducting this research. Intervention 2: Control group: Patients will be given 2 gr of powder (350 mg of xylooligosaccharides and 36 mg of fructooliosacaride as prebiotics without probiotic strain twice a day for 4 weeks. This product has been also made by Zist-Takhmir company. Participants will be given the necessary training before conducting this research. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Will be done after the end of the study.
public Nima Afshari pour
Emam Khomeini Avenue
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8500 nimaa770@gmail.com Tehran University of Medical Sciences scientific Hadi Ahmadi Amoli
Emam Khomeni Avenue
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8500 ahmadam@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age 18 to 57 years Indicated removal of the anterior part of the lower rectum Confirmed adenocarcinoma Ability to fill out a questionnaire Patients with Rectal cancers whom undergone radiotherapy 18 years 57 years Both Use antibiotics or probiotics a week before Systemic evidence of obstruction in preoperative endoscopy Urinary and fecal incontinence Metastatic cancer Advanced cardiovascular and cerebral disease Pregnant and lactating mothers Irritable Bowel Syndrome History of chemotherapy or radiotherapy Symptoms of infection or immunodeficiency disease Abnormal creatinine Abnormal liver enzymes Uncontrolled hypertension or diabetes Patients with celiac disease or probiotic intolerance C18.9 Malignant neoplasm of colon, unspecified Treatment - Drugs Placebo Intervention group: Multilateral probiotics in the form of LactoCare capsules made by Zist-Takhmir Company will be given to patients every 12 hours (after lunch and after dinner) for 4 weeks. Participants will be given the necessary training before conducting this research. Control group: Patients will be given 2 gr of powder (350 mg of xylooligosaccharides and 36 mg of fructooliosacaride as prebiotics without probiotic strain twice a day for 4 weeks. This product has been also made by Zist-Takhmir company. Participants will be given the necessary training before conducting this research. Level of Quality of Life. Timepoint: The questionnaire will be completed by the patients of both groups once before starting the drug treatment and after that by the patient every week. Method of measurement: The Gastrointestinal Quality of Life Questionnaire consists of 36 different items that include general and specific symptoms, physical and mental functioning, and social dysfunction related to gastrointestinal diseases. Each item has a score from 0 to 4. The score of this questionnaire is from 0 to 144, of which 0 is the worst possible case and 144 is the best possible case. The Anterior Resect Syndrome Questionnaire examines 5 important questions, including 1. Incontinence for stool 2. Incontinence for liquid stool 3. Frequency 4. Clustering 5. Urgency. The score of this questionnaire is from 0 to 42, according to which if the patient scores 0 to 20, he does not have anterior resection syndrome. A score of 21 to 29 indicates a mild form of the syndrome, and a score of 30 to 42 indicates a severe form. Tehran University of Medical Sciences Approved 2021-07-03 Ethics Committee of Tehran University of Medical Sciences Keshavarz Boulevard, corner of Quds Tehran Tehran Iran (Islamic Republic of)