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Evaluation of the effects of capsules containing probiotics on metabolic parameters, oxidative stress and clinical symptoms of age-related macular degeneration

 View older revisions Content changed at 2022-12-31, 1401/10/10

Protocol summary

Study aim
Determination of the effect of probiotic capsule on metabolic parameters, oxidative stress and clinical signs of age-related macular degeneration (AMD), 1397 in Kashan
Design
This study will be designed as a clinical trial.Double-blind control-placebo is performed on 70 patients with ARMD in the range of 50-85 years old. First, patients are identified based on biochemical findings and a fundoscopic finding with ARMD history.Then they are treated with one of the treatment groups or placebo
Settings and conduct
This clinical trial is performed on 70 individuals with age-related macular degeneration which referred to Kashan Matini Hospital.Individuals based on random Blocks (one per group) will be divided to probotic or placebo capsule,one per day for 2 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
Entrance criteria: aged 50 to 85 years, diminished vision solely due to AMD Exit criteria: corneal opacity, diabetes, history of retinal vascular disorders, history of retina tear, history of penetrating trauma
Intervention groups
Intervention group: probiotic capsule 500 mg, produced in tak gene company, ,One number per day for 2 months orally. Control group: placebo capsule 500 Mg, produced in tak gene company, ,One number per day for 2 months orally.
Main outcome variables
Fasting blood glucose Plasma; Insulin Serum; Insulin resistance; Hs-CRP; Total glutathione; Macular thickness; Visual acuity

General information

Reason for update
Due to changes occur during the trial
Acronym
IRCT registration information
IRCT registration number: IRCT20130211012438N30
Registration date: 2019-02-19, 1397/11/30
Registration timing: retrospective

Last update: 2022-12-31, 1401/10/10
Update count: 1
Registration date
2019-02-19, 1397/11/30
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
2019-01-20, 1397/10/30
Scientific title
Evaluation of the effects of capsules containing probiotics on metabolic parameters, oxidative stress and clinical symptoms of age-related macular degeneration
Public title
The effect of probiotic capsule on patients with macular degeneration associated with age
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Reduced vision simply because of AMD
Exclusion criteria:
Corneal opacity Diabetes History of retinal vascular disorders History of retina tear History of penetrating trauma
Age
From 50 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 70
Actual sample size reached: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Random Blocks (one per group): Patients will be divided into two groups, probiotic (case) and placebo (control ). The division of selected subjects will be done randomly in blocks of study using quadrilateral blocks. The division of selected subjects will be done in randomized blocks using six rows of four blocks (ABAB-BABA-ABBA-BAAB-AABB-BBAA). probiotic capsule (A) and placebo group (B). In this way, different scenarios are written on six cards and will be thrown into a bag and 60 cards will be written out of the bag for 15 times, and the order will be written in a sheet.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drugs and placebo are in the same packaging at the Barij Essence pharmaceutical company . Only the code is written on the packages. Patients and physician do not know the type of drug and after analyzing the data, packet codes are decoded.
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
2017-12-11, 1396/09/20
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1396.16

Health conditions studied

1

Description of health condition studied
Age-related macular degeneration
ICD-10 code
H35.3
ICD-10 code description
Degeneration of macula and posterior pole

Primary outcomes

1

Description
High sensitive-Critical Reactive Protein
Timepoint
At the beginning of the study and2 months after the start of the study
Method of measurement
ELISA

Secondary outcomes

1

Description
Visual Acuity
Timepoint
At the beginning of the study and 2 months after the start of the study
Method of measurement
Visual Acuity check with Snellen chart

2

Description
Macular thickness
Timepoint
At the beginning of the study and 2 months after the start of the study
Method of measurement
Central Macular Thickness Evaluate with OCT Instrument

3

Description
Fasting plasma glucose
Timepoint
At the beginning of the study and 2 months after the start of the study
Method of measurement
Enzymatic Kits

4

Description
Triglycerides
Timepoint
At the beginning of the study and 2 months after the start of the study
Method of measurement
Enzymatic Kits

5

Description
Low density lipoprotein-cholesterol
Timepoint
At the beginning of the study and 2 months after the start of the study
Method of measurement
Enzymatic Kits

6

Description
High density lipoprotein-cholesterol
Timepoint
At the beginning of the study and 2 months after the start of the study
Method of measurement
Enzymatic Kits

7

Description
Total cholesterol
Timepoint
At the beginning of the study and 2 months after the start of the study
Method of measurement
Enzymatic Kits

8

Description
Very low density lipoprotein-cholesterol
Timepoint
At the beginning of the study and 2 months after the start of the study
Method of measurement
Standard formula

9

Description
Nitric oxide
Timepoint
At the beginning of the study and 2 months after the start of the study
Method of measurement
Photospectrometry

10

Description
Malondialdehyde
Timepoint
At the beginning of the study and 2 months after the start of the study
Method of measurement
Photospectrometry

11

Description
Glutathion
Timepoint
At the beginning of the study and 2 months after the start of the study
Method of measurement
Photospectrometry

12

Description
Total Anti Oxidant
Timepoint
At the beginning of the study and 2 months after the start of the study
Method of measurement
Photospectrometry

13

Description
Insulin
Timepoint
At the beginning of the study and 2 months after the start of the study
Method of measurement
ELISA

14

Description
QUICKI
Timepoint
At the beginning of the study and 2 months after the start of the study
Method of measurement
Standard formula

15

Description
HOMA-IR
Timepoint
At the beginning of the study and 2 months after the start of the study
Method of measurement
Standard formula

Intervention groups

1

Description
Intervention group: probiotic capsule 500 MG,produced in tak gene company,One number per day for 2 months orally.
Category
Treatment - Drugs

2

Description
Control group: placebo capsule500 MG, produced in Tak gene company, ,One number per day for 2 months 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
Kashan University of Medical Sciences, Qotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5554 2999
Email
banafsheh_h@kaums.ac.ir
Web page address
http://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
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Kashan University of Medical Sciences, 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
mMohsen Taghizadeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Kashan University of Medical Sciences, Qotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8719675537
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
Mohsen Taghizadeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Kashan University of Medical Sciences,Qotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
871967537
Phone
+98 31 5533 3213
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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