Effects of synbiotic treatment on Uremic index in End stage renal disease
Design
In this research, 46 eligible patients referring to nor and aliasghar hospital chosen purposefully and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups.
Settings and conduct
place: nor and aliasghar hospital
blind: researcher and patient
Participants/Inclusion and exclusion criteria
Inclusion criteria
performing hemodialysis treatment 3-times per week for at least 4 hours each time; not being pregnant or lactating; no history of active cancers (except for skin cancer); no history of severe chronic conditions such as pulmonary, cardiovascular, and hepatic diseases; no history of gastrointestinal disorders, HIV disease, and psychiatric problems.
Exclusion criteria
addiction to alcohol or drugs abuse; with severe edema; suffering from infections during 4 past weeks; those who used symbiotic, probiotic, prebiotic or antibiotics during 4 weeks preceding the study; those who used immune suppressive medicines, and anticoagulant agents were excluded
Gasttro-Resistant Capsules of synbiotic Reduced blood uremic toxins in hemodialysis patients: double-blind placebo-controlled randomized clinical trial.
Public title
Symbiotic and blood uremic toxins in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
performing hemodialysis treatment 3-times per week for at least 4 hours each time,
not being pregnant or lactating
no history of active cancers (except for skin cancer)
no history of severe chronic conditions such as pulmonary, cardiovascular, and hepatic diseases
lack of gastrointestinal disorders, HIV disease, and psychiatric problems
Exclusion criteria:
those who used symbiotic, probiotic, prebiotic or antibiotics during 4 weeks preceding the study
those who used immune suppressive medicines, and anticoagulant agents
with severe edema
addiction to alcohol or drugs abuse
did not respond to the questions honestly
and reported any side effects due to synbiotic consumption
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Dual block Subjects will randomly allocated to block 1 and block 2 with the use of stratif block randomization according to gender, age (± 5 years) and hemodialysis duration (± 6 months).
Blinding (investigator's opinion)
Double blinded
Blinding description
double-blind
To conduct the study in a double-blinded nature, the placebo and synbiotic capsules will encode as A and B, respectively, by a third person and patients and investigators will blind about the arms of the study
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University Of Medical Sciences
Street address
International Bureau, Isfahan University of Medical Sciences, P.O. Box 319, Hezar-Jerib Ave., Isfahan, IR Iran, 81746 73461
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Approval date
2015-11-15, 1394/08/24
Ethics committee reference number
194053
Health conditions studied
1
Description of health condition studied
end stage renal disease
ICD-10 code
I95.3
ICD-10 code description
Hypotension of hemodialysis
Primary outcomes
1
Description
indoxyl sulfate
Timepoint
1 and 8 weeks of treatment
Method of measurement
Eliza kit
2
Description
crp
Timepoint
1 and 8 weeks of treatment
Method of measurement
Eliza kit
Secondary outcomes
1
Description
phenol
Timepoint
1 and 8 weeks of treatment
Method of measurement
hplc
Intervention groups
1
Description
synbiotic The synbiotic capsules (GeriLact brand; ZIST TAKHMIR Company, Tehran; Iran) contained Lactobacillus casei (3.5×109CFU), Lactobacillus acidophilus (1.5×109CFU), Lactobacillus rhamnosus (3×109CFU), Lactobacillus bulgaricus (3.5×108CFU), Bifidobacterium breve (5×109CFU), Bifidobacterium longum (1×1010CFU), Streptococcus thermophiles (3.5×108CFU) as probiotic and fructooligosaccharide as prebiotic as well as lactose, magnesium stearate and talc as filling materials.During the 8-week intervention, the synbiotic group will receive 2 synbiotic capsules daily, between the main meals (500 mg per one capsule; onecapsule per time), containing 1000mgsynbiotic
Category
Treatment - Drugs
2
Description
placebo maltodextrin (2 capsules per day; 1000mg).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan’s Noor and Saint Aliasghar Hospital’s dialysis
Full name of responsible person
Mohammad Hassan Entezari
Street address
Hezar-Jerib Ave
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3792 3071
Email
soheila.mirzaeian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan university of medical sciences; research assistant part
Full name of responsible person
Soheila Mirzaeian
Street address
Hezar-Jerib Ave., Isfahan, IR Iran
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 4274 1499
Email
soheila.mirzaeian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan university of medical sciences; research assistant part
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
2
Sponsor
Name of organization / entity
Food Safety Research Center
Full name of responsible person
Mohammadhassan Entezari
Street address
Hezarjrib
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 0048
Email
soheila.mirzaeian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Food Safety Research Center
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
School of Nutrition and Food Sciences, Isfahan University of Medical Sciences
Full name of responsible person
Soheila Mirzaeian
Position
phd student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Hezar-Jerib Ave., Isfahan, IR Iran
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 4274 1499
Fax
Email
soheila.mirzaeian@nutr.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Clinical Nutrition, School of Nutrition and Food Sciences, Isfahan University of Medic
Full name of responsible person
Mohammad Hassan Entezari
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Isfahn
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 317922752
Fax
+98 31 3668 7898
Email
entezari@hlth.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Clinical Nutrition, School of Nutrition and Food Sciences, Isfahan University of Medic
Full name of responsible person
Soheila Mirzaeian
Position
phd student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Isfahan
City
Isfahan
Province
Isfehan
Postal code
81647-2384
Phone
+98 31 4274 1499
Fax
+98 31 3668 7898
Email
soheila.mirzaeian@nutr.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
all data except personal data
When the data will become available and for how long
2 year after pablication
To whom data/document is available
academic researcher
Under which criteria data/document could be used
honest
From where data/document is obtainable
soheila.mirzaeian@yahoo.com
What processes are involved for a request to access data/document