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IRCT201504182017N21 IRCT 2015-05-23 Vice chancellor for research, Tabriz University of Medical Sciences Effects of Lactobacillus Rhamnosus and Inulin supplements (singly & both) on phenolic uremic toxins, nutritional status and Functional GI Disorders (FGIDs) in hemodialysis patients Effects of Lactobacillus Rhamnosus and Inulin supplements (singly & both) on phenolic uremic toxins, nutritional status and FGIDs in hemodialysis patients 2015-05-22 anticipated 96 Complete https://irct.ir/trial/1637 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive. N/A End stage kidney disease on dialysis. Intervention 1: Intervention group: Probiotic; Lactobacillus Rhamnosus (16 Billion CFU) one capsule per day for 28 days, after meal, prepared by Nutrition Research Center from yogurt and cheese of different farms located in the suburbs Heris. Intervention 2: Intervention group: Prebiotic; Inulin (10 grams) one sachet per day for 28 days, after meal, soluble dietary and ferment-able fiber, prepared by BENEO Belgium from Cichorium intybus. Intervention 3: Intervention group: Symbiotic; Lactobacillus Rhamnosus (16 Billion CFU, one capsule) with Inulin (10 grams, one sachet) per day for 28 days, after meal. Intervention 4: Control group: Corn starch (10 grams, one sachet) with Infant formula (one capusule) per day, for 28 days after meal, (Placebo).
public Farzad Eidi
Faculty of Nutrition, Tabriz University of Medical Sciences, Attar Neishaboori Avenue, Golgasht Street, Tabriz
Tabriz Iran (Islamic Republic of) +98 41 3335 2292 farzadeidi@gmail.com Faculty of Nutrition, Tabriz University of Medical Sciences scientific Alireza Ostadrahimi
Faculty of Nutrition, Tabriz University of Medical Sciences, Attar neishaboori Avenue, Golgasht Street, Tabriz
Tabriz Iran (Islamic Republic of) +98 41 3335 2292 ostadrahimi@tbzmed.ac.ir Nutrition Research Center, Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: Physician definitive diagnosis of end stage of renal disease (ESRD) treated by hemodialysis; both male and female; aged 20 years and older; acceptable performance of the digestive system; ability to drink at least 100 ml of water per day; life expectancy and survival at least 3 months; absence of acute medical conditions; accept and sign the project. Exclusion criteria: Patient reluctance to participate in the study; treated with peritoneal dialysis or kidney transplantation; intolerance supplements; pregnant women; lactating women; smoking; acute medical illness; use of antibiotics; use of psychedelic drugs; use of herbal medicines and flavors. 19 years 99 years Both N18.5 Chronic kidney disease, stage 5 Treatment - Other Treatment - Other Treatment - Other Placebo Intervention group: Probiotic; Lactobacillus Rhamnosus (16 Billion CFU) one capsule per day for 28 days, after meal, prepared by Nutrition Research Center from yogurt and cheese of different farms located in the suburbs Heris. Intervention group: Prebiotic; Inulin (10 grams) one sachet per day for 28 days, after meal, soluble dietary and ferment-able fiber, prepared by BENEO Belgium from Cichorium intybus. Intervention group: Symbiotic; Lactobacillus Rhamnosus (16 Billion CFU, one capsule) with Inulin (10 grams, one sachet) per day for 28 days, after meal. Control group: Corn starch (10 grams, one sachet) with Infant formula (one capusule) per day, for 28 days after meal, (Placebo) Serum levels of Phenol. Timepoint: Before and after intervention. Method of measurement: By HPLC method. Serum levels of Paracresol. Timepoint: Before and after intervention. Method of measurement: By HPLC method. Anthropometric measurements, Weight. Timepoint: Before and after intervention. Method of measurement: Weight using calibrated Seca scale with a precision of 0.1 kg. Energy intake. Timepoint: Before and after intervention. Method of measurement: 3 days food recall was used and analyzed with Nutritionist 4 software. FGIDs, Symptoms in the Esophagus. Timepoint: Before and after intervention. Method of measurement: Using 93 items questionnaire based on ROM III. FGIDs, Symptoms in the Stomach & Intestines. Timepoint: Before and after intervention. Method of measurement: Using 93 items questionnaire based on ROM III. Anthropometric measurements, Body Mass Index. Timepoint: Before and after intervention. Method of measurement: Calculate: Weight divided to Square of Height. Macronutrient intake, Proteins. Timepoint: Before and after intervention. Method of measurement: 3 days food recall was used and analyzed with Nutritionist 4 software. Macronutrient intake, Fats. Timepoint: Before and after intervention. Method of measurement: 3 days food recall was used and analyzed with Nutritionist 4 software. Macronutrient intake, Carbohydrates. Timepoint: Before and after intervention. Method of measurement: 3 days food recall was used and analyzed with Nutritionist 4 software. FGIDs, Symptoms in the Gall Bladder & Pancreas. Timepoint: Before and after intervention. Method of measurement: Using 93 items questionnaire based on ROM III. FGIDs, Symptoms in the Rectum & Anal canal. Timepoint: Before and after intervention. Method of measurement: Using 93 items questionnaire based on ROM III. Intestinal (Stool) Microbiome, Bacteroidetes. Timepoint: Before and After Intervention. Method of measurement: Real-time PCR of DNA extracted from stool sample. Intestinal (Stool) Microbiome, Firmicotes. Timepoint: Before and After Intervention. Method of measurement: Real-time PCR of DNA extracted from stool sample. Vice chancellor for research, Shahid Beheshti university of Medical Sciences Vice chancellor for research, Tabriz University of Medical Sciences Vice chancellor for research, Shahid Beheshti university of Medical Sciences Approved 2015-03-09 Ethics committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Attar Neishaboori Avenue, Golgasht Street, Tabriz Tabriz Iran (Islamic Republic of)