End stage kidney disease on dialysis. Chronic kidney disease, stage 5
Conditions
Interventions
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. In
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
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)
Sponsors
Vice chancellor for research, Tabriz University of Medical Sciences
Vice chancellor for research, Shahid Beheshti university of Medical Sciences
Eligibility
Sex/Gender
All
Age
19 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFarzad Eidi
Faculty of Nutrition, Tabriz University of Medical Sciences
Outcome results
None listed