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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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History
# Registration date Revision Id
2 2022-07-31, 1401/05/09 235494
1 2019-01-26, 1397/11/06 76899
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  • Protocol summary

    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.
    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.
    این کارآزمایی بالینی بر روی 60 فرد مبتلا به رتینوپاتی دیابتی مراجعه کننده به بیمارستان متینی کاشان اجرا می شود. افراد بر اساس جدول اعداد تصادفی به 2 گروه درمان کپسول پروبیوتیک یا پلاسبو روزانه 1عدد به صورت خوراکی برای 3ماه تقسیم خواهند شد. افراد ماهانه به صورت تلفنی پیگیری می شوند و در ابتدا و انتهای مطالعه ویزیت حضوری شده و آزمایشات و معاینات برای آنها انجام می شود. داروها در بسته بندی مشابه عرضه می شود و پزشک و بیمار، محقق، و آنالیز کننده آماری از نوع آن بی خبرند و پس از پایان آنالیز داده ها کدها رمز گشایی می شوند.
    این کارآزمایی بالینی بر روی 72 فرد مبتلا به رتینوپاتی دیابتی مراجعه کننده به بیمارستان متینی کاشان اجرا می شود. افراد بر اساس جدول اعداد تصادفی به 2 گروه درمان کپسول پروبیوتیک یا پلاسبو روزانه 1عدد به صورت خوراکی برای 3ماه تقسیم خواهند شد. افراد ماهانه به صورت تلفنی پیگیری می شوند و در ابتدا و انتهای مطالعه ویزیت حضوری شده و آزمایشات و معاینات برای آنها انجام می شود. داروها در بسته بندی مشابه عرضه می شود و پزشک و بیمار، محقق، و آنالیز کننده آماری از نوع آن بی خبرند و پس از پایان آنالیز داده ها کدها رمز گشایی می شوند.

  • General information

    60
    72
    empty
    55
    empty
    2018-05-20, 1397/02/30
    empty
    2018-11-21, 1397/08/30
    empty
    2018-11-21, 1397/08/30
    empty
    Due to changes occur during the trial
    empty
    به علت تغییرات ایجاد شده در زمان انجام مطالعه

  • Primary outcomes

    #1
    fasting blood sugar
    HOMA-IR
    قند خون ناشتا
    شاخص مقاومت یه انسولین
    laboratory kit
    Standard formula
    کیت آزمایشگاهی
    فرمول استاندارد
    #2
    Stress Oxidation Indicators (Total Plasma Antioxidant, Total Glutathione, and Malondialdehyde Plasma)
    Macular thickness
    شاخص های استرس اکسیداتیو(توتال آنتی اکسیدانت پلاسمایی، گلوتاتیون توتال و مالون دی آلدئید پلاسما)
    ضخامت ماکولا
    Blood test
    Central Macular Thickness Evaluate with OCT Instrument
    آزمایش خون
    اندازه گیری ضخامت ماکولا بر حسب میکرومتر و با دستگاه OCT صورت می گیرد
    #3
    Macular thickness
    empty
    ضخامت ماکولا
    empty
    At the beginning of the study and three months after the start of the study
    empty
    ابتدای مطالعه و سه ماه پس از شروع مطالعه
    empty
    Central Macular Thickness Evaluate with OCT Instrument
    empty
    اندازه گیری ضخامت ماکولا بر حسب میکرومتر و با دستگاه OCT صورت می گیرد
    empty
    #4
    Triglyceride
    empty
    تری گلیسیرید
    empty
    At the beginning of the study and three months after the start of the study
    empty
    ابتدای مطالعه و سه ماه پس از شروع مطالعه
    empty
    laboratory kit
    empty
    کیت آزمایشگاهی
    empty
    #5
    low density lipoprotein
    empty
    لیپوپروتئین با وزن مولکولی پایین
    empty
    At the beginning of the study and three months after the start of the study
    empty
    ابتدای مطالعه و سه ماه پس از شروع مطالعه
    empty
    laboratory kit
    empty
    کیت آزمایشگاهی
    empty
    #6
    High density lipoprotein
    empty
    لیپوپروتئین با وزن مولکولی بالا
    empty
    At the beginning of the study and three months after the start of the study
    empty
    ابتدای مطالعه و سه ماه پس از شروع مطالعه
    empty
    laboratory kit
    empty
    کیت آزمایشگاهی
    empty
    #7
    high sensitive-Critical Reactive Protein
    empty
    پروتئین واکنشی C باحساسیت بالا
    empty
    At the beginning of the study and three months after the start of the study
    empty
    ابتدای مطالعه و سه ماه پس از شروع مطالعه
    empty
    laboratory kit
    empty
    کیت آزمایشگاهی
    empty

  • Secondary outcomes

    #1
    empty
    Total Anti Oxidant (TAC)
    empty
    ظرفیت تام آنتی اکسیدانی
    empty
    At the beginning and the end of the study
    empty
    در ابتدا و انتهای مطالعه
    empty
    Photospectrometry
    empty
    فتواسپکترومتری
    #2
    empty
    Glutathion
    empty
    گلوتاتیون
    empty
    At the beginning and the end of the study
    empty
    در ابتدا و انتهای مطالعه
    empty
    Photospectrometry
    empty
    فتواسپکترومتری
    #3
    empty
    Malondialdehyde
    empty
    مالون دی آلدهید
    empty
    At the beginning and the end of the study
    empty
    در ابتدا و انتهای مطالعه
    empty
    Photospectrometry
    empty
    فتواسپکترومتری
    #4
    empty
    Nitric oxide
    empty
    نیتریک اکسید
    empty
    At the beginning and the end of the study
    empty
    در ابتدا و انتهای مطالعه
    empty
    Photospectrometry
    empty
    فتواسپکترومتری
    #5
    empty
    High sensitive-C reactive protein(hs-CRP)
    empty
    پروتئین واکنشگر C با حساسیت بالا
    empty
    At the beginning and the end of the study
    empty
    در ابتدا و انتهای مطالعه
    empty
    ELISA
    empty
    الایزا
    #6
    empty
    HbA1C
    empty
    هموگلوبین A1C
    empty
    At the beginning and the end of the study
    empty
    در ابتدا و انتهای مطالعه
    empty
    Enzymatic Kits
    empty
    کیت آنزیمی
    #7
    empty
    Fasting plasma glucose
    empty
    قند پلاسمای ناشتا
    empty
    At the beginning and the end of the study
    empty
    در ابتدا و انتهای مطالعه
    empty
    Enzymatic Kits
    empty
    کیت آنزیمی
    #8
    empty
    Insulin
    empty
    انسولین
    empty
    At the beginning and the end of the study
    empty
    در ابتدا و انتهای مطالعه
    empty
    ELISA
    empty
    الایزا
    #9
    empty
    Triglyceride
    empty
    تری گلیسیرید
    empty
    At the beginning and the end of the study
    empty
    در ابتدا و انتهای مطالعه
    empty
    Enzymatic Kits
    empty
    کیت آنزیمی
    #10
    empty
    Total cholesterol
    empty
    کلسترول تام
    empty
    At the beginning and the end of the study
    empty
    در ابتدا و انتهای مطالعه
    empty
    Enzymatic Kits
    empty
    کیت آنزیمی
    #11
    empty
    Very low density lipoprotein-cholesterol (VLDL-ch)
    empty
    لیپوپروتئین با چگالی بسیار پایین-کلسترول
    empty
    At the beginning and the end of the study
    empty
    در ابتدا و انتهای مطالعه
    empty
    Standard formula
    empty
    فرمول استاندارد
    #12
    empty
    High density lipoprotein-cholesterol (HDL-ch)
    empty
    لیپوپروتئین با چگالی بالا-کلسترول
    empty
    At the beginning and the end of the study
    empty
    در ابتدا و انتهای مطالعه
    empty
    Enzymatic Kits
    empty
    کیت آنزیمی
    #13
    empty
    Low density lipoprotein-cholesterol (VLDL-ch)
    empty
    لیپوپروتئین با چگالی پایین-کلسترول
    empty
    At the beginning and the end of the study
    empty
    در ابتدا و انتهای مطالعه
    empty
    Enzymatic Kits
    empty
    کیت آنزیمی
    #14
    empty
    QUICKI
    empty
    شاخص حساسیت به انسولین
    empty
    At the beginning and the end of the study
    empty
    در ابتدا و انتهای مطالعه
    empty
    Standard formula
    empty
    فرمول استاندارد

  • Intervention groups

    #1
    Intervention group: probiotic capsule ,One number per day for 3 months orally.
    Intervention group: probiotic capsule ,One number per day for 12 weeks orally.
    گروه مداخله:کپسول پروبیوتیک روزانه 1 عدد به صورت خوراکی برای مدت 3 ماه
    گروه مداخله:کپسول پروبیوتیک روزانه 1 عدد به صورت خوراکی برای مدت 12 هفته
    #2
    Control group: placebo capsule ,One number per day for 3 months orally.
    Control group: placebo capsule ,One number per day for 12 weeks orally.
    گروه کنترل:کپسول پلاسبو روزانه 1 عدد به صورت خوراکی برای مدت 3 ماه
    گروه کنترل:کپسول پلاسبو روزانه 1 عدد به صورت خوراکی برای مدت 12 هفته

  • Recruitment centers

    #1
    Name of recruitment center - English: matini hospital
    Name of recruitment center - Persian: بیمارستان متینی کاشان
    Full name of responsible person - English: Hasan Farajipoor
    Full name of responsible person - Persian: حسن فرجی
    Street address - English: Iran, Kashan, Amir Kabir Street, Matini Hospital
    Street address - Persian: ایران ، کاشان ، خیابان امیرکبیر ،بیمارستان متینی کاشان
    City - English: kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 81151-87159
    Phone: +98 31 5534 4271
    Fax:
    Email: farajipoor_h@kaums.ac.ir
    Web page address:
    Name of recruitment center - English: Matini Hospital
    Name of recruitment center - Persian: بیمارستان متینی کاشان
    Full name of responsible person - English: Hasan Farajipoor
    Full name of responsible person - Persian: حسن فرجی پور
    Street address - English: Matini Hospital, Amir Kabir Street, Kashan,Iran
    Street address - Persian: ایران، کاشان، خیابان امیرکبیر، بیمارستان متینی کاشان
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 81151-87159
    Phone: +98 31 5534 4271
    Fax:
    Email: farajipoor_h@kaums.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hamid Reza Banafshe
    Full name of responsible person - Persian: حمید رضا بنفشه
    Street address - English: Kashan University of Medical Sciences, Kashan, Iran
    Street address - Persian: ایران ، کاشان ، بلوار قطب راوندی ، دانشگاه علوم پزشکی کاشان
    City - English: kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 81151-87159
    Phone: +98 31 5554 0021
    Fax:
    Email: banafsheh_h@kaums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hamid Reza Banafshe
    Full name of responsible person - Persian: حمید رضا بنفشه
    Street address - English: School of Medicine, Qotbe Ravandi Boulevard, Kashan
    Street address - Persian: ایران ، کاشان ، بلوار قطب راوندی ، دانشگاه علوم پزشکی کاشان
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 81151-87159
    Phone: +98 31 5554 0021
    Fax:
    Email: banafsheh_h@kaums.ac.ir
    Web page address:

Protocol summary

Study aim
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 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.
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.
Main outcome variables
Fasting plasma glucose; serum Insulin; Insulin resistance Hs-CRP; Total glutathione; Macular thickness; Visual acuity; Hemoglobin A1C

General information

Reason for update
Due to changes occur during the trial
Acronym
IRCT registration information
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
Registration date
2019-01-26, 1397/11/06
Registrant information
Name
Mohsen Taghizadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
taghizadeh_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-20, 1397/02/30
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
2018-05-20, 1397/02/30
Actual recruitment end date
2018-11-21, 1397/08/30
Trial completion date
2018-11-21, 1397/08/30
Scientific title
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: 72
Actual sample size reached: 55
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,Qotbe Ravandi Boulevard, Kashan
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
HOMA-IR
Timepoint
At the beginning of the study and three months after the start of the study
Method of measurement
Standard formula

3

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

Secondary outcomes

1

Description
Total Anti Oxidant (TAC)
Timepoint
At the beginning and the end of the study
Method of measurement
Photospectrometry

2

Description
Glutathion
Timepoint
At the beginning and the end of the study
Method of measurement
Photospectrometry

3

Description
Malondialdehyde
Timepoint
At the beginning and the end of the study
Method of measurement
Photospectrometry

4

Description
Nitric oxide
Timepoint
At the beginning and the end of the study
Method of measurement
Photospectrometry

5

Description
High sensitive-C reactive protein(hs-CRP)
Timepoint
At the beginning and the end of the study
Method of measurement
ELISA

6

Description
HbA1C
Timepoint
At the beginning and the end of the study
Method of measurement
Enzymatic Kits

7

Description
Fasting plasma glucose
Timepoint
At the beginning and the end of the study
Method of measurement
Enzymatic Kits

8

Description
Insulin
Timepoint
At the beginning and the end of the study
Method of measurement
ELISA

9

Description
Triglyceride
Timepoint
At the beginning and the end of the study
Method of measurement
Enzymatic Kits

10

Description
Total cholesterol
Timepoint
At the beginning and the end of the study
Method of measurement
Enzymatic Kits

11

Description
Very low density lipoprotein-cholesterol (VLDL-ch)
Timepoint
At the beginning and the end of the study
Method of measurement
Standard formula

12

Description
High density lipoprotein-cholesterol (HDL-ch)
Timepoint
At the beginning and the end of the study
Method of measurement
Enzymatic Kits

13

Description
Low density lipoprotein-cholesterol (VLDL-ch)
Timepoint
At the beginning and the end of the study
Method of measurement
Enzymatic Kits

14

Description
QUICKI
Timepoint
At the beginning and the end of the study
Method of measurement
Standard formula

Intervention groups

1

Description
Intervention group: probiotic capsule ,One number per day for 12 weeks orally.
Category
Treatment - Drugs

2

Description
Control group: placebo capsule ,One number per day for 12 weeks orally.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Matini Hospital
Full name of responsible person
Hasan Farajipoor
Street address
Matini Hospital, Amir Kabir Street, Kashan,Iran
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
School of Medicine, Qotbe Ravandi Boulevard, Kashan
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
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