Effects of Lactobacillus Rhamnosus and Inulin supplements (singly & both) on phenolic uremic toxins, nutritional status and FGIDs in hemodialysis patients
Objectives: Effects of Lactobacillus Rhamnosus and Inulin supplements (singly & both) on phenolic uremic toxins; nutritional status and FGIDs in hemodialysis patients. Design: Double blind randomized clinical trial. Setting and conduct: 96 eligible ESRD treated by hemodilysis which meet the inclusion criteria during will be selected and blocked randomly divided into 3 intervention group: a)Probiotic Lactobacillus Rhamnosus b)Prebiotic Inulin c)Symbiotic Lactobacillus Rhamnosus and Inulin; Control group: Placebo. Intervention: Target group receives 16 billion CFU probiotic Lactobacillus Rhamnosus per day as one capsule after meal for 28 days (prepared by Nutrition Research Center from yogurt and cheese of different farms located in the suburbs Heris), and receives 10 grams per day prebiotic Inulin as one sachet after meal for 28 days, soluble dietary and ferment-able fiber, (prepared by BENEO Belgium from Cichorium intybus). Control group receives 10 g per day corn starch as one placebo sachet and one placebo capsule per day infant formula after meal for 28 days. Major Inclusion criteria: Both male and female; aged 20 years and older; acceptable performance of the digestive system; ability to drink at least 200 ml of water per day; life expectancy and survival at least 3 months; absence of acute medical conditions; accept and sign the project. Major Exclusion criteria: Patient reluctance to participate in the study; treated by peritoneal dialysis or kidney transplantation; intolerance supplements; pregnant women; lactating women; smoking; acute medical illness; use of antibiotics; psychedelic drugs; herbal medicines or flavors. Main primary outcome measures: The effect of supplements on serum levels of Uremic toxins (Paracresol and Phenol); nutrition status; energy intake; macronutrient intake; anthropometric measurements (weight, BMI), and FGIDs. Secondary outcome measures: The effect of supplements on intestinal and fecal microbiome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201504182017N21
Registration date:2015-05-23, 1394/03/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-05-23, 1394/03/02
Registrant information
Name
Alireza Ostadrahimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
ostadrahimi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Tabriz University of Medical Sciences, Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Lactobacillus Rhamnosus and Inulin supplements (singly & both) on phenolic uremic toxins, nutritional status and FGIDs in hemodialysis patients
Public title
Effects of Lactobacillus Rhamnosus and Inulin supplements (singly & both) on phenolic uremic toxins, nutritional status and Functional GI Disorders (FGIDs) in hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion 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.
Age
From 19 years old to 99 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Attar Neishaboori Avenue, Golgasht Street, Tabriz
City
Tabriz
Postal code
Approval date
2015-03-09, 1393/12/18
Ethics committee reference number
93197
Health conditions studied
1
Description of health condition studied
End stage kidney disease on dialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Serum levels of Phenol
Timepoint
Before and after intervention
Method of measurement
By HPLC method
2
Description
Serum levels of Paracresol
Timepoint
Before and after intervention
Method of measurement
By HPLC method
3
Description
Anthropometric measurements, Weight
Timepoint
Before and after intervention
Method of measurement
Weight using calibrated Seca scale with a precision of 0.1 kg
4
Description
Energy intake
Timepoint
Before and after intervention
Method of measurement
3 days food recall was used and analyzed with Nutritionist 4 software
5
Description
FGIDs, Symptoms in the Esophagus
Timepoint
Before and after intervention
Method of measurement
Using 93 items questionnaire based on ROM III
6
Description
FGIDs, Symptoms in the Stomach & Intestines
Timepoint
Before and after intervention
Method of measurement
Using 93 items questionnaire based on ROM III
7
Description
Anthropometric measurements, Body Mass Index
Timepoint
Before and after intervention
Method of measurement
Calculate: Weight divided to Square of Height
8
Description
Macronutrient intake, Proteins
Timepoint
Before and after intervention
Method of measurement
3 days food recall was used and analyzed with Nutritionist 4 software
9
Description
Macronutrient intake, Fats
Timepoint
Before and after intervention
Method of measurement
3 days food recall was used and analyzed with Nutritionist 4 software
10
Description
Macronutrient intake, Carbohydrates
Timepoint
Before and after intervention
Method of measurement
3 days food recall was used and analyzed with Nutritionist 4 software
11
Description
FGIDs, Symptoms in the Gall Bladder & Pancreas
Timepoint
Before and after intervention
Method of measurement
Using 93 items questionnaire based on ROM III
12
Description
FGIDs, Symptoms in the Rectum & Anal canal
Timepoint
Before and after intervention
Method of measurement
Using 93 items questionnaire based on ROM III
Secondary outcomes
1
Description
Intestinal (Stool) Microbiome, Bacteroidetes
Timepoint
Before and After Intervention
Method of measurement
Real-time PCR of DNA extracted from stool sample
2
Description
Intestinal (Stool) Microbiome, Firmicotes
Timepoint
Before and After Intervention
Method of measurement
Real-time PCR of DNA extracted from stool sample
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
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.
Category
Treatment - Other
3
Description
Intervention group: Symbiotic; Lactobacillus Rhamnosus (16 Billion CFU, one capsule) with Inulin (10 grams, one sachet) per day for 28 days, after meal.
Category
Treatment - Other
4
Description
Control group: Corn starch (10 grams, one sachet) with Infant formula (one capusule) per day, for 28 days after meal, (Placebo)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Labbafinejhad Hospital
Full name of responsible person
Fatemeh Pourrezagholi
Street address
9th Boostan Avenue, Pasdaran Street, Tehran
City
Tehran
2
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Alireza Ostadrahimi
Street address
Azadi Street, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Rashidi
Street address
Tabriz University of Medical Sciences, Attar Neishaboori Avenue, Golgasht Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti university of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
ShahidBeheshti Universityof Medical Sciences, Velenjak Street, Shahid Chamran High Way, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Beheshti university of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Nutrition, Tabriz University of Medical Sciences
Full name of responsible person
Farzad Eidi
Position
MD, Ph.D Student of Nutrition
Other areas of specialty/work
Street address
Faculty of Nutrition, Tabriz University of Medical Sciences, Attar Neishaboori Avenue, Golgasht Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 2292
Fax
Email
farzadeidi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nutrition Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostadrahimi
Position
Professor, MD, Ph.D of Nutrition Sciences
Other areas of specialty/work
Street address
Faculty of Nutrition, Tabriz University of Medical Sciences, Attar neishaboori Avenue, Golgasht Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 2292
Fax
Email
ostadrahimi@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nutrition, Tabriz University of Medical Sciences
Full name of responsible person
Farzad Eidi
Position
MD, Ph.D Student of Nutrition
Other areas of specialty/work
Street address
Faculty of Nutrition, Tabriz University of Medical Sciences, Attar neishaboori Avenue, Golgasht Street
City
Tabriz
Postal code
Phone
00
Fax
Email
farzadeidi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)