The aim of this study is evaluate the effects of probiotics on the bacterial endotoxin level of serum, as an indicator of intestinal immunity, and to compare it with the level of endotoxins in patients receiving dialysis stool. Study design: After explaining the purpose of the study and obtaining the informed consent, patients will be randomly allocated into test and control groups. Randomization will be performed using random block sizes of 4. The study is randomized, single-center, phase 3 trial. Inclusion criteria : Patients with minimum age of 18 years old and estimated glomerular filtration (GFR) rate of less than 15 ml. Exclusion criteria: Patients with active infectious conditions within the previous 30 days of the study, pregnancy; autoimmune diseases, being on immunosuppressive agents or consumption of antibiotics within 30 days prior to enrolment. Sample size: 60 patients. The intervention used in the study: one capsule of probiotics three times a week after dialysis and one capsule before bedtime in the rest of weekdays for six months. The Endotoxin level of serum and fecal samples will be then measured again and the obtained data will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016103130603N1
Registration date:2017-04-14, 1396/01/25
Registration timing:prospective
Last update:
Update count:1
Registration date
2017-04-14, 1396/01/25
Registrant information
Name
Alireza Jafar
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
alireza.jafar@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahroud University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotics on the serum and fecal levels of endotoxin in hemodialysis patients
Public title
The effect of probiotics on infectious disease in hemodialysis patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Signing a written consent to participate in the research; minimum age of 18 years old with estimated glomerular filtration rate of less than 15 ml, having a normal diet and conventional dairy.
Exclusion criteria: Lack of patient's consent for participation in the research, Patients with Infectious disease; pregnancy, lactose intolerance, autoimmune or immunosuppressive disease, being on treatment with immune-suppressing drugs or anti-biotics within 30 days prior to the start of study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Reasearch will be randomised using blocked randomization design.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical Sciences
Street address
Haft-e-Tir Square, Shahroud, Iran
City
Shahroud
Postal code
3613773955
Approval date
2016-10-08, 1395/07/17
Ethics committee reference number
ir.shmu.rec.1395.113
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease
Primary outcomes
1
Description
Serum and fecal level of endotoxin
Timepoint
before intervenrion and at the end of intervention (after 6 months)