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The effect of lactulose on administration on nitrogen waste products in patients with chronic renal failure

Protocol summary

Summary
The aim of the present study is to assess the effect of lactolose prebiotic on nitrogen waste products in patients with chronic renal failure (CRF). This study would be a randomized placebo-controlled single-center clinical trial. The inclusion criteria would be the patients with stages 3 and 4 of CRF, the patients who are older than 18 years of age and the patients who have consent to continue the study. The exclusion criteria would be the history of any probiotic, sinbiotic and antibiotic use during one month prior to the study, patients with intolerance to lactolose or patients how create complications. We will randomly select 40 patients after consideration of all inclusion and exclusion criteria. The entire patients will receive 30cc lactolose suspension three times a day for two months. A blood sample will be taken from the study patients before the initiation of lactolose therapy, after two-month therapy and one month later than two-month therapy. Biochemical parameters will include levels of sodium, potassium, hemoglobin, hematocrit, blood urea nitrogen (BUN), creatinine, C-reactive protein (CRP), P-Cresol, Indoxyl Sulfate, β-2 microglobulin and parathyroid hormone (PTH). White blood cell (WBC) count will also be considered.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201105316666N1
Registration date: 2012-01-07, 1390/10/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-01-07, 1390/10/17
Registrant information
Name
Bita Rahbari
Name of organization / entity
Tabriz University Of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5921
Email address
rahbarib@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University Of Medical Sciences and Health Services
Expected recruitment start date
2011-06-22, 1390/04/01
Expected recruitment end date
2011-08-22, 1390/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lactulose on administration on nitrogen waste products in patients with chronic renal failure
Public title
The effect of lactulose on administration on nitrogen waste products
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :1)The patients with stages 3 and 4 of CRF 2The patients who are older than 18 years of age3) The patients who have consent to continue the study. Exclusion criteria:1) History of any probiotic, sinbiotic and antibiotic use during one month prior to the study2) patients with intolerance to lactolose or patients how create complications.
Age
From 18 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University Of Medical Sciences and Health Services
Street address
Tabriz University Of Medical Sciences and Health Services, Golgasht Ave, Tabriz
City
Tabriz
Postal code
5166614756
Approval date
2011-06-14, 1390/03/24
Ethics committee reference number
5/4/2332

Health conditions studied

1

Description of health condition studied
Chrontic Renal Failure stages 3
ICD-10 code
N18.3
ICD-10 code description
Moderate Chronic Renal Failure (stage 3)

2

Description of health condition studied
Chronic Renal Failure (stage 4)
ICD-10 code
N18.4
ICD-10 code description
Severe Chronic Renal Failure (stage 4)

Primary outcomes

1

Description
p-cresyl sulfate
Timepoint
at the end of the study and 1 month after the study
Method of measurement
at the end of the study and 1 month after the study

2

Description
Indoxyl sulfate
Timepoint
at the end of the study and 1 month after the study
Method of measurement
High Performance Liquid Chromatography = HPLC

3

Description
Advanaced Glycation End (AGE) Products
Timepoint
at the end of the study and 1 month after the study
Method of measurement
High Performance Liquid Chromatography = HPLC

Secondary outcomes

1

Description
C-Reactive Protein = CRP
Timepoint
at the end of the study and after 1 month
Method of measurement
Standard lab test

Intervention groups

1

Description
Lactolose suspension 30 ml/min three times a day for two months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz Emam Reza Hospital
Full name of responsible person
Dr.Bita Rahbari
Street address
Emam Reza Hospital , Golgasht Ave, Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University Of Medical Sciences and Health Services
Full name of responsible person
Miss Maghami
Street address
Tabriz University Of Medical Sciences and Health Services, Golgasht Ave, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University Of Medical Sciences and Health Services
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
Tabriz University Of Medical Sciences and Health Services
Full name of responsible person
Dr.Bita Rahbari
Position
Rezident Of Internal Medicin
Other areas of specialty/work
Street address
Tabriz University Of Medical Sciences and Health Services , Golgasht Ave, Tabriz
City
Tabriz
Postal code
5166614756
Phone
+98 41 1335 5921
Fax
+98 41 1335 5944
Email
Rahbarib@tbzmed.ac.ir
Web page address
www.tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hamid T. Khosroshahi
Position
MD, Subspeciality in Nephrology
Other areas of specialty/work
Street address
Department of Internal Medicine, Emam Reza Hospital, Golgasht St.
City
Tabriz
Postal code
5166614756
Phone
+98 41 1337 8093
Fax
+98 41 1337 8093
Email
drtayebikh@yahoo.com
Web page address
www.tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University Of Medical Sciences and Health Services
Full name of responsible person
Dr.Bita Rahbari
Position
Rezident Of Internal Medicine
Other areas of specialty/work
Street address
Tabriz University Of Medical Sciences and Health Services , Golgasht Ave, Tabriz
City
Tabriz
Postal code
5166614756
Phone
+98 41 1335 5921
Fax
+98 413355944
Email
Rahbarib@tbzmed.ac.ir
Web page address
www.tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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