Protocol summary
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Study aim
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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.
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Design
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Randomized clinical trial, double blind, controlled with placebo, parallel, single center
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Settings and conduct
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This clinical trial is performed on 72 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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Intervention group: probiotic capsule ,One number per day for 3 months orally.
Control group: placebo capsule ,One number per day for 3 months orally.
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Main outcome variables
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Fasting plasma glucose; serum Insulin; Insulin resistance
Hs-CRP; Total glutathione; Macular thickness; Visual acuity;
Hemoglobin A1C
General information
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Reason for update
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Due to changes occur during the trial
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20130211012438N29
Registration date:
2019-01-26, 1397/11/06
Registration timing:
retrospective
Last update:
2022-08-03, 1401/05/12
Update count:
1
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Registration date
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2019-01-26, 1397/11/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-05-20, 1397/02/30
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Expected recruitment end date
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2018-11-21, 1397/08/30
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Actual recruitment start date
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2018-05-20, 1397/02/30
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Actual recruitment end date
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2018-11-21, 1397/08/30
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Trial completion date
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2018-11-21, 1397/08/30
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Scientific title
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The effect of probiotic food supplement on metabolic parameters, oxidative stress and clinical symptoms in patients with diabetic retinopathy
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Public title
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the effects of capsules containing probiotics on diabetic retinopathy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 70 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
72
Actual sample size reached:
55
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomized based on table of random numbers
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-12-12, 1396/09/21
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Ethics committee reference number
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IR.KAUMS.NUHEPM.REC.1396.15
Health conditions studied
1
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Description of health condition studied
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Diabetic retinopathy
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ICD-10 code
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H36.0
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ICD-10 code description
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Diabetic retinopathy
Primary outcomes
1
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Description
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Visual Acuity
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Timepoint
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At the beginning of the study and three months after the start of the study
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Method of measurement
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Visual Acuity check with snellen chart
2
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Description
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HOMA-IR
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Timepoint
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At the beginning of the study and three months after the start of the study
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Method of measurement
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Standard formula
3
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Description
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Macular thickness
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Timepoint
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At the beginning of the study and three months after the start of the study
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Method of measurement
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Central Macular Thickness Evaluate with OCT Instrument
Secondary outcomes
1
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Description
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Total Anti Oxidant (TAC)
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Timepoint
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At the beginning and the end of the study
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Method of measurement
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Photospectrometry
2
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Description
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Glutathion
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Timepoint
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At the beginning and the end of the study
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Method of measurement
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Photospectrometry
3
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Description
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Malondialdehyde
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Timepoint
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At the beginning and the end of the study
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Method of measurement
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Photospectrometry
4
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Description
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Nitric oxide
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Timepoint
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At the beginning and the end of the study
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Method of measurement
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Photospectrometry
5
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Description
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High sensitive-C reactive protein(hs-CRP)
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Timepoint
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At the beginning and the end of the study
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Method of measurement
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ELISA
6
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Description
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HbA1C
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Timepoint
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At the beginning and the end of the study
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Method of measurement
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Enzymatic Kits
7
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Description
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Fasting plasma glucose
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Timepoint
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At the beginning and the end of the study
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Method of measurement
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Enzymatic Kits
8
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Description
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Insulin
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Timepoint
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At the beginning and the end of the study
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Method of measurement
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ELISA
9
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Description
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Triglyceride
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Timepoint
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At the beginning and the end of the study
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Method of measurement
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Enzymatic Kits
10
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Description
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Total cholesterol
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Timepoint
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At the beginning and the end of the study
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Method of measurement
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Enzymatic Kits
11
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Description
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Very low density lipoprotein-cholesterol (VLDL-ch)
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Timepoint
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At the beginning and the end of the study
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Method of measurement
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Standard formula
12
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Description
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High density lipoprotein-cholesterol (HDL-ch)
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Timepoint
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At the beginning and the end of the study
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Method of measurement
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Enzymatic Kits
13
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Description
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Low density lipoprotein-cholesterol (VLDL-ch)
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Timepoint
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At the beginning and the end of the study
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Method of measurement
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Enzymatic Kits
14
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Description
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QUICKI
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Timepoint
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At the beginning and the end of the study
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Method of measurement
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Standard formula
Intervention groups
1
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Description
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Intervention group: probiotic capsule ,One number per day for 12 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Control group: placebo capsule ,One number per day for 12 weeks orally.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available