The effect of dietary supplement containing probiotic on metabolic parameters and clinical signs of diabetic retinopathy (DR) in patients referring to Matini Hospital in Kashan, 2018.
Design
Randomized clinical trial, double blind, controlled with placebo, parallel, single center
Settings and conduct
This clinical trial is performed on 60 individuals with diabetic retinopathy which referred to Kashan Matini Hospital.Individuals based on table of random numbers will be divided to probotic or placebo capsule,one per day for 3 months. Individuals checked by the phone monthly and at the beginning and end of the study they will have a visit and blood tests and clinical examinations will be done for them. All drug are presented in the same package and the physician , patients, researcher and statistical analyst are blind .After analyzing data, codes will be decoded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 20 to 70 years; Have each stage of diabetic retinopathy; Normal intraocular pressure
Non inclusion criteria:
Corneal opacity; Intra-vitreous hemorrhage of the retina; Retinal problems with the exception of diabetic retinopathy; Glaucoma disease or high refractive error; History of any previous retinal treatment; Other diseases of the retina and optic nerve; Ocular hypertension
Intervention groups
Intervention group: probiotic capsule ,One number per day for 3 months orally.
Control group: placebo capsule ,One number per day for 3 months orally.
The effect of probiotic food supplement on metabolic parameters, oxidative stress and clinical symptoms in patients with diabetic retinopathy
Public title
the effects of capsules containing probiotics on diabetic retinopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have each stage of diabetis retinopathy
Normal intraocular pressure
Exclusion criteria:
Corneal opacity
Intra-vitreous hemorrhage of the retina, with the exception of diabetic retinopathy
Glaucoma disease or high refractive errors
History of any previous retinal treatment
Other diseases of the retina and optic nerve
Ocular hypertension
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized based on table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
Coding and similar packaging will be used for blinding. Therefore, the physician, patient, researcher and statistical analyzer are blind to the content of the packages. At the end of the study and analysis of data, decoding will be done.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Kashan, Iran
City
kashan
Province
Isfehan
Postal code
8115187159
Approval date
2017-12-12, 1396/09/21
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1396.15
Health conditions studied
1
Description of health condition studied
Diabetic retinopathy
ICD-10 code
H36.0
ICD-10 code description
Diabetic retinopathy
Primary outcomes
1
Description
Visual Acuity
Timepoint
At the beginning of the study and three months after the start of the study
Method of measurement
Visual Acuity check with snellen chart
2
Description
fasting blood sugar
Timepoint
At the beginning of the study and three months after the start of the study
Method of measurement
laboratory kit
3
Description
Stress Oxidation Indicators (Total Plasma Antioxidant, Total Glutathione, and Malondialdehyde Plasma)
Timepoint
At the beginning of the study and three months after the start of the study
Method of measurement
Blood test
4
Description
Macular thickness
Timepoint
At the beginning of the study and three months after the start of the study
Method of measurement
Central Macular Thickness Evaluate with OCT Instrument
5
Description
Triglyceride
Timepoint
At the beginning of the study and three months after the start of the study
Method of measurement
laboratory kit
6
Description
low density lipoprotein
Timepoint
At the beginning of the study and three months after the start of the study
Method of measurement
laboratory kit
7
Description
High density lipoprotein
Timepoint
At the beginning of the study and three months after the start of the study
Method of measurement
laboratory kit
8
Description
high sensitive-Critical Reactive Protein
Timepoint
At the beginning of the study and three months after the start of the study
Method of measurement
laboratory kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: probiotic capsule ,One number per day for 3 months orally.
Category
Treatment - Drugs
2
Description
Control group: placebo capsule ,One number per day for 3 months orally.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
matini hospital
Full name of responsible person
Hasan Farajipoor
Street address
Iran, Kashan, Amir Kabir Street, Matini Hospital
City
kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5534 4271
Email
farajipoor_h@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafshe
Street address
Kashan University of Medical Sciences, Kashan, Iran
City
kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5554 0021
Email
banafsheh_h@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
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
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hasan Farajipoor
Position
Assistant Professor professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
School of Medicine, Qotbe Ravandi Boulevard, Kashan
City
kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5554 0021
Email
farajipoor_h@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohsen Taghizadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Medicine, Qotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5533 3213
Email
taghizadeh_m@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
MohsenTaghizadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Medicine, Qotbe Ravandi Boulevard, Kashan,Iran
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 3198
Email
taghizadeh_m@kaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available