The purpose of this study is " determination of the effect of probiotic supplementation on patients' Hemoglobin with chronic Renal failure on Hemodialysis. The study is a double blind intervention study with random allocation that it done in two Hemodialysis center. 36 patients are allocted randomly in two intervention and control groups (each groups18 patients). The main inclusion criteria includes:
Hemoglobin concentration <11g/dL in at least 3 episode;
CRP more than 10 mg/ lit;
Erythropoietin therapy for at least 4 weeks;
Hemodialysis treatment for at least 6 months;
3 times dialysis per week and 4 hours per session;
No surgery or bleeding in the last 3 months;
Absence of active infection;
No Consumption antibiotics in 10 days ago;
No Hospitalization;
Exclusion criteria:
Antibiotictherapy during the study;
Hospitalization;
No Patient's tendency to stay in study;
Bleeding during the study;
The patients in intervention groups will receive oral probiotic supplement capsules 500mg per day after a meal for 12 weeks.
The Patients in control group will receive one oral Placebo capsules per day for 12 weeks after a meal. Hemoglobin, CRP, were measured Before the intervention and three episode after intervantion With each month interval and then compare groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013072710325N2
Registration date:2015-01-09, 1393/10/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-09, 1393/10/19
Registrant information
Name
Gholamreza Mahmoodi Shan
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1442 6900
Email address
mahmoudi@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Golestan University of Medical Sciences, Gorgan, Iran.
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotic supplementation on patients' Hemoglobin with chronic Renal failure on Hemodialysis,
Public title
The effect of probiotic supplementation on patients' Anemia with chronic Renal failure on Hemodialysis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Over 17 years old;
Both sexess;
Erythropoietin therapy for at least 4 weeks;
Hemodialysis treatment for at least 6 months;
3 times dialysis per week and 4 hours per session;
Hemoglobin concentration <11g/dL in at least 3 episode;
CRP more than 10 mg/ lit;
No sever hyperparathyroidism;
No surgery or bleeding in the last 3 months;
Lack of Hemoglobin disorder including: Thalassemia or Sickle cell anemia;
Lack of iron deficiency;
Lack of folate and vitamin B12 deficiency;
Absence of active infection;
Lack of immune disorders such as Lupus erythematosus;
Absence of malignancy;
No Alcohol consuming;
No Consumption antibiotics in 10 days ago;
No Consumption corticosteroids;
Lack of viral infections: AIDS;
No Hospitalization;
Exclusion criteria:
Antibiotic therapy during the study;
Hospitalization;
Blood transfusion during the study;
Surgery during the study;
Change in drug program that it is effective on the anemia;
Change in dialysis program;
No Patient's tendency to stay in study;
Malignancy diagnosis during the study;
The presence of bleeding disorders during the study;
Age
From 17 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
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
Ethical Committee Golestan University of Medical Sciences
Street address
Deputy of Research and Technology, Golestan University, Shastkola
City
gorgan
Postal code
Approval date
2014-06-08, 1393/03/18
Ethics committee reference number
562089303182
Health conditions studied
1
Description of health condition studied
End stage kidney disease on hemodialysis
ICD-10 code
N18.5
ICD-10 code description
End stage kidney disease
Primary outcomes
1
Description
Hemoglobin measurement
Timepoint
Before the intervention and three episode after intervantion With each month interval
Method of measurement
Laboratory equipment.
Secondary outcomes
1
Description
Quantitative CRP
Timepoint
Before the intervention and three episode after intervantion With each month interval
Method of measurement
Laboratory equipment.
2
Description
Blood presure
Timepoint
Three months before and three months after the intervention
Method of measurement
manometer
3
Description
Defecation pattern
Timepoint
Before the intervention and after the intervention three times with an interval of one month
Method of measurement
Bristol scale and patient statement
Intervention groups
1
Description
The intervention group consisted of 18 patients that they will receive oral probiotic supplement capsule, 500 mg per day for 12 weeks, after a meal.
Category
Treatment - Drugs
2
Description
The control group consisted of 18 patients that they will receive oral Placebo capsules, one number per day for 12 weeks, after a meal.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
5 AZAR Hospital
Full name of responsible person
zahra shariaty
Street address
5 AZAR Hospital, 5 AZAR Street
City
Gorgan
2
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
zahra shariaty
Street address
Imam Hossein Hospital, Imam street
City
Shahrood
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research andTechnology, Golestan University
Full name of responsible person
DR.masoud khoshnia
Street address
Deputy of Research and Technology, Golestan University, Shastkola
City
gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research andTechnology, Golestan University
Proportion provided by this source
100
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
Golestan University of Medical Sciences
Full name of responsible person
zahra shariaty
Position
Ms Student of Critical Nursing Care
Other areas of specialty/work
Street address
Bouyeh School of Nursing & Midwifery, Golestan Universityo f Medical Sciences
City
gorgan
Postal code
Phone
+98 17 3242 1660
Fax
Email
zshariaty@ymail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Gholamreza Mahmoodi Shan
Position
PhD, Assistant Professor
Other areas of specialty/work
Street address
Bouyeh School of Nursing & Midwifery, Golestan University of Medical Sciences, Shastkola
City
Gorgan
Postal code
Phone
+98 17 3242 1660
Fax
Email
mahmoodigh@yahoo.com; mahmoodigh1392@Goums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
DR.Gholamreza Mahmoodi Shan
Position
PhD, Assistant Professor
Other areas of specialty/work
Street address
Bouyeh School of Nursing & Midwifery, Golestan University of Medical Sciences, Shastkola
City
Gorgan
Postal code
Phone
+98 17 3242 1660
Fax
Email
mahmoodigh@yahoo.com; mahmoodigh1392@Goums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)