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Protocol summary
Inclusion:
Diabetic nephropathy with microalbuminuria (Albuminuria 30-299 mg / g Cr, eGFR≥ 30 ml / min / 1.73m2), age 20 to 60 years, BMI less than 40 kg / m2
Exclusion: History of chronic diseases including: IBD, liver disease, rheumatoid arthritis, renal disorders other than diabetic nephropathy, smoking and alcohol and tobacco use, history of antibiotics and NSAIDs during a recent month, use Omega-3 supplementation and vitamins E, C during the last three months, taking probiotic supplements or foods containing probiotics during the last three months, lactose intolerance, pregnancy, insulin injection
Inclusion:
Diabetic nephropathy with microalbuminuria (Albuminuria 30-299 mg / g Cr, eGFR≥ 30 ml / min / 1.73m2), age 20 to 80 years, BMI less than 40 kg / m2
Exclusion: History of chronic diseases including: IBD, liver disease, rheumatoid arthritis, renal disorders other than diabetic nephropathy, smoking and alcohol and tobacco use, history of antibiotics and NSAIDs during a recent month, use Omega-3 supplementation and vitamins E, C during the last three months, taking probiotic supplements or foods containing probiotics during the last three months, lactose intolerance, pregnancy
Inclusion: Diabetic nephropathy with microalbuminuria (Albuminuria 30-299 mg / g Cr, eGFR≥ 30 ml / min / 1.73m2), age 20 to 6080 years, BMI less than 40 kg / m2 Exclusion: History of chronic diseases including: IBD, liver disease, rheumatoid arthritis, renal disorders other than diabetic nephropathy, smoking and alcohol and tobacco use, history of antibiotics and NSAIDs during a recent month, use Omega-3 supplementation and vitamins E, C during the last three months, taking probiotic supplements or foods containing probiotics during the last three months, lactose intolerance, pregnancy, insulin injection
معیارهای ورود:
ابتلا به نفروپاتی دیابتی دارای میکروآلبومینوری ( Albuminuria 30-299 mg/g Cr ,eGFR≥30 ml/min/1.73m2)، سن 60-20 سال،BMI کمتر از kg/m2 40
معیارهای عدم ورود : سابقه ابتلا به بیماری های مزمن از جمله: IBD، بیماری های کبدی، آرتریت روماتویید، اختلالات کلیوی به جز نفروپاتی دیابتی،استعمال سیگار و الکل و دخانیات،سابقه مصرف آنتی بیوتیک ها و NSAID در طی یک ماه اخیر ،مصرف مکمل امگا3 و ویتامین های E,C در طی سه ماه اخیر،مصرف مکمل پروبیوتیک یا مواد غذایی حاوی پروبیوتیک در طی سه ماه اخیر،عدم تحمل لاکتوز،باردار بودن فرد، تزریق انسولین
معیارهای ورود:
ابتلا به نفروپاتی دیابتی دارای میکروآلبومینوری ( Albuminuria 30-299 mg/g Cr ,eGFR≥30 ml/min/1.73m2)، سن 80-20 سال،BMI کمتر از kg/m2 40
معیارهای عدم ورود : سابقه ابتلا به بیماری های مزمن از جمله: IBD، بیماری های کبدی، آرتریت روماتویید، اختلالات کلیوی به جز نفروپاتی دیابتی،استعمال سیگار و الکل و دخانیات،سابقه مصرف آنتی بیوتیک ها و NSAID در طی یک ماه اخیر ،مصرف مکمل امگا3 و ویتامین های E,C در طی سه ماه اخیر،مصرف مکمل پروبیوتیک یا مواد غذایی حاوی پروبیوتیک در طی سه ماه اخیر،عدم تحمل لاکتوز،باردار بودن فرد
معیارهای ورود: ابتلا به نفروپاتی دیابتی دارای میکروآلبومینوری ( Albuminuria 30-299 mg/g Cr ,eGFR≥30 ml/min/1.73m2)، سن 6080-20 سال،BMI کمتر از kg/m2 40 معیارهای عدم ورود : سابقه ابتلا به بیماری های مزمن از جمله: IBD، بیماری های کبدی، آرتریت روماتویید، اختلالات کلیوی به جز نفروپاتی دیابتی،استعمال سیگار و الکل و دخانیات،سابقه مصرف آنتی بیوتیک ها و NSAID در طی یک ماه اخیر ،مصرف مکمل امگا3 و ویتامین های E,C در طی سه ماه اخیر،مصرف مکمل پروبیوتیک یا مواد غذایی حاوی پروبیوتیک در طی سه ماه اخیر،عدم تحمل لاکتوز،باردار بودن فرد، تزریق انسولین
General information
70
80
7080
2021-01-09, 1399/10/20
2021-11-11, 1400/08/20
2021-0111-0911 00:00:00
2021-01-29, 1399/11/10
2021-12-11, 1400/09/20
2021-0112-2911 00:00:00
empty
Due to the prevalence of Covid-19 and the decrease in the number of patients with the desired criteria, a number of criteria have been revised and due to the delay of the steps, the date of the intervention has also changed. Elimination of the criterion of not including insulin injecting people, increasing the age range of people, replacing the morning fasting urine method with a 24-hour urine test and changing the intervention date
Due to the prevalence of Covid-19 and the decrease in the number of patients with the desired criteria, a number of criteria have been revised and due to the delay of the steps, the date of the intervention has also changed. Elimination of the criterion of not including insulin injecting people, increasing the age range of people, replacing the morning fasting urine method with a 24-hour urine test and changing the intervention date
empty
با توجه به شیوع کووید-19 و کاهش تعداد بیماران با معیارهای مورد نظر در مورد تعدادی از معیارها تجدید نظر شده و به علت عقب افتادن مراحل تاریخ انجام مداخله نیز تغییر کرده است. حذف معیار عدم ورود افراد تزریق کننده انسولین، افزایش بازه سنی افراد، جایگزینی روش ادرار ناشتا صبحگاهی با جای ادرار 24 ساعته و تغییر تاریخ مداخله
با توجه به شیوع کووید-19 و کاهش تعداد بیماران با معیارهای مورد نظر در مورد تعدادی از معیارها تجدید نظر شده و به علت عقب افتادن مراحل تاریخ انجام مداخله نیز تغییر کرده است. حذف معیار عدم ورود افراد تزریق کننده انسولین، افزایش بازه سنی افراد، جایگزینی روش ادرار ناشتا صبحگاهی با جای ادرار 24 ساعته و تغییر تاریخ مداخله
Diabetic nephropathy with microalbuminuria (Albuminuria 30-299 mg / g Cr, eGFR≥ 30 ml / min / 1.73m2)
Has an age of 70-20 years
BMI less than 40 kg / m2
Diabetic nephropathy with microalbuminuria (Albuminuria 30-299 mg / g Cr, eGFR≥ 30 ml / min / 1.73m2)
Has an age of 80-20 years
BMI less than 40 kg / m2
Diabetic nephropathy with microalbuminuria (Albuminuria 30-299 mg / g Cr, eGFR≥ 30 ml / min / 1.73m2) Has an age of 7080-20 years BMI less than 40 kg / m2
ابتلا به نفروپاتی دیابتی دارای میکروآلبومینوری (( Albuminuria 30-299 mg/g Cr ,eGFR≥30 ml/min/1.73m2
دارای سن 70-20 سال
BMI کمتر از kg/m2 40
ابتلا به نفروپاتی دیابتی دارای میکروآلبومینوری (( Albuminuria 30-299 mg/g Cr ,eGFR≥30 ml/min/1.73m2
دارای سن 80-20 سال
BMI کمتر از kg/m2 40
ابتلا به نفروپاتی دیابتی دارای میکروآلبومینوری (( Albuminuria 30-299 mg/g Cr ,eGFR≥30 ml/min/1.73m2 دارای سن 7080-20 سال BMI کمتر از kg/m2 40
History of chronic diseases including: IBD, liver disease, rheumatoid arthritis, renal disorders except diabetic nephropathy
Smoking, alcohol and tobacco
History of taking antibiotics and NSAIDS (during the last month)
Take omega 3 supplements and vitamins E and C during the last three months
Consumption of probiotic supplements or foods containing probiotics during the last three months
Lactose intolerance
Pregnancy
Insulin injection
History of chronic diseases including: IBD, liver disease, rheumatoid arthritis, renal disorders except diabetic nephropathy
Smoking, alcohol and tobacco
History of taking antibiotics and NSAIDS (during the last month)
Take omega 3 supplements and vitamins E and C during the last three months
Consumption of probiotic supplements or foods containing probiotics during the last three months
Lactose intolerance
Pregnancy
History of chronic diseases including: IBD, liver disease, rheumatoid arthritis, renal disorders except diabetic nephropathy Smoking, alcohol and tobacco History of taking antibiotics and NSAIDS (during the last month) Take omega 3 supplements and vitamins E and C during the last three months Consumption of probiotic supplements or foods containing probiotics during the last three months Lactose intolerance Pregnancy Insulin injection
سابقه ابتلا به بیماری های مزمن از جمله: IBD، بیماری های کبدی، آرتریت روماتویید، اختلالات کلیوی به جز نفروپاتی دیابتی
استعمال سیگار و الکل و دخانیات
سابقه مصرف آنتی بیوتیک ها و NSAID در طی یک ماه اخیر
مصرف مکمل امگا3 و ویتامین های E,C در طی سه ماه اخیر
مصرف مکمل پروبیوتیک یا مواد غذایی حاوی پروبیوتیک در طی سه ماه اخیر
عدم تحمل لاکتوز
باردار بودن فرد
تزریق انسولین
سابقه ابتلا به بیماری های مزمن از جمله: IBD، بیماری های کبدی، آرتریت روماتویید، اختلالات کلیوی به جز نفروپاتی دیابتی
استعمال سیگار و الکل و دخانیات
سابقه مصرف آنتی بیوتیک ها و NSAID در طی یک ماه اخیر
مصرف مکمل امگا3 و ویتامین های E,C در طی سه ماه اخیر
مصرف مکمل پروبیوتیک یا مواد غذایی حاوی پروبیوتیک در طی سه ماه اخیر
عدم تحمل لاکتوز
باردار بودن فرد
سابقه ابتلا به بیماری های مزمن از جمله: IBD، بیماری های کبدی، آرتریت روماتویید، اختلالات کلیوی به جز نفروپاتی دیابتی استعمال سیگار و الکل و دخانیات سابقه مصرف آنتی بیوتیک ها و NSAID در طی یک ماه اخیر مصرف مکمل امگا3 و ویتامین های E,C در طی سه ماه اخیر مصرف مکمل پروبیوتیک یا مواد غذایی حاوی پروبیوتیک در طی سه ماه اخیر عدم تحمل لاکتوز باردار بودن فرد تزریق انسولین
Recruitment centers
#1
Name of recruitment center - English: کلینیک دیابت بیمارستان امام خمینی تهران
Name of recruitment center - Persian: Diabetes Clinic of Imam Khomeini Hospital, Tehran
Full name of responsible person - English: Seyed Mojtaba Ghoreishy
Full name of responsible person - Persian: سید مجتبی قریشی
Street address - English: Imam Khomeini Hospital, at the end of Keshavarz Boulevard, Dr. Gharib Street, Tehran, Tehran Province
Street address - Persian: استان تهران، تهران، انتهای بلوار کشاورز، خیابان دکتر قریب، بیمارستان امام خمینی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۱۹۷۳۳۱۴۱
Phone: +98 21 6119 0000
Fax:
Email: Imamhospital@tums.ac.ir
Web page address:
Name of recruitment center - English: Diabetes Clinic of Imam Khomeini Hospital, Tehran
Name of recruitment center - Persian: کلینیک دیابت بیمارستان امام خمینی تهران
Full name of responsible person - English: Seyed Mojtaba Ghoreishy
Full name of responsible person - Persian: سید مجتبی قریشی
Street address - English: Imam Khomeini Hospital, at the end of Keshavarz Boulevard, Dr. Gharib Street, Tehran, Tehran Province
Street address - Persian: استان تهران، تهران، انتهای بلوار کشاورز، خیابان دکتر قریب، بیمارستان امام خمینی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1419733141
Phone: +98 21 6119 0000
Fax:
Email: Imamhospital@tums.ac.ir
Web page address:
Name of recruitment center - English: کلینیک دیابت بیمارستان امام خمینی تهران Name of recruitment center - Persian: Diabetes Clinic of Imam Khomeini Hospital, Tehran Name of recruitment center - Persian: کلینیک دیابت بیمارستان امام خمینی تهران Full name of responsible person - English: Seyed Mojtaba Ghoreishy Full name of responsible person - Persian: سید مجتبی قریشی Street address - English: Imam Khomeini Hospital, at the end of Keshavarz Boulevard, Dr. Gharib Street, Tehran, Tehran Province Street address - Persian: استان تهران، تهران، انتهای بلوار کشاورز، خیابان دکتر قریب، بیمارستان امام خمینی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۴۱۹۷۳۳۱۴۱1419733141 Phone: +98 21 6119 0000 Fax: Email: Imamhospital@tums.ac.ir Web page address:
Protocol summary
Study aim
If appropriate, it is recommended to use probiotic yogurt in the diet of patients with type 2 diabetes with nephropathy
Design
Controlled, parallel, double-blind clinical trial, people with diabetic nephropathy, 60 people; randomization by rand function of Excel software
Settings and conduct
Controlled, parallel, double-blind clinical trial, in Imam Khomeini Hospital Diabetes Clinic, before the intervention, anthropometric assessments, glycemic indexes, renal indices, blood lipid indices, inflammatory markers and blood pressure indices in all individuals are assessed. The software will randomly divide participants into intervention and control groups; intervention: 300 g daily probiotic yogurt for 8 weeks, control: 300 g normal yogurt daily for 8 weeks. The yogurts have the same color, shape, taste and smell are used so that the researcher and the patient are not aware of its type and only our distributor is aware of its type.
Participants/Inclusion and exclusion criteria
Inclusion:
Diabetic nephropathy with microalbuminuria (Albuminuria 30-299 mg / g Cr, eGFR≥ 30 ml / min / 1.73m2), age 20 to 80 years, BMI less than 40 kg / m2
Exclusion: History of chronic diseases including: IBD, liver disease, rheumatoid arthritis, renal disorders other than diabetic nephropathy, smoking and alcohol and tobacco use, history of antibiotics and NSAIDs during a recent month, use Omega-3 supplementation and vitamins E, C during the last three months, taking probiotic supplements or foods containing probiotics during the last three months, lactose intolerance, pregnancy
Intervention groups
Intervention: daily 300g probiotic yogurt for 8 weeks, control: 300g normal yogurt for 8 weeks
Due to the prevalence of Covid-19 and the decrease in the number of patients with the desired criteria, a number of criteria have been revised and due to the delay of the steps, the date of the intervention has also changed. Elimination of the criterion of not including insulin injecting people, increasing the age range of people, replacing the morning fasting urine method with a 24-hour urine test and changing the intervention date
Acronym
IRCT registration information
IRCT registration number:IRCT20201125049491N1
Registration date:2020-12-28, 1399/10/08
Registration timing:prospective
Last update:2021-07-18, 1400/04/27
Update count:2
Registration date
2020-12-28, 1399/10/08
Registrant information
Name
Seyed Mojtaba Ghoreishy
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 4222 8244
Email address
seyed.mojtaba.ghoreishy@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-11, 1400/08/20
Expected recruitment end date
2021-12-11, 1400/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotic yogurt consumption on albuminuria, eGFR and metabolic parameters in type 2 diabetic patients with nephropathy
Public title
The effect of probiotic yogurt consumption on albuminuria, eGFR and metabolic parameters in type 2 diabetic patients with nephropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic nephropathy with microalbuminuria (Albuminuria 30-299 mg / g Cr, eGFR≥ 30 ml / min / 1.73m2)
Has an age of 80-20 years
BMI less than 40 kg / m2
Exclusion criteria:
History of chronic diseases including: IBD, liver disease, rheumatoid arthritis, renal disorders except diabetic nephropathy
Smoking, alcohol and tobacco
History of taking antibiotics and NSAIDS (during the last month)
Take omega 3 supplements and vitamins E and C during the last three months
Consumption of probiotic supplements or foods containing probiotics during the last three months
Lactose intolerance
Pregnancy
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Each person is assigned a code and this code is entered into Excel software, and then used to randomize the rand function of Excel software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape, appearance, packaging, color and smell of both probiotic and non-probiotic yogurts will be quite similar. In addition, the person who provides yogurts to patients is aware of the type of yogurt, but the researcher and the patient are not aware of it.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
First Floor, Faculty of Medicine, Building No. 1, North Door of the University, POURSINA St, GHODS St, ENGHELAB St
City
Tehran
Province
Tehran
Postal code
14155-6117
Approval date
2020-09-19, 1399/06/29
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.458
Health conditions studied
1
Description of health condition studied
Diabetic nephropathy
ICD-10 code
E11.21
ICD-10 code description
Type 2 diabetes mellitus with diabetic nephropathy
Primary outcomes
1
Description
Urinary albumin
Timepoint
First the intervention and 8 weeks later at the end of the intervention
Method of measurement
Laboratory kits
Secondary outcomes
1
Description
eGFR
Timepoint
At the beginning of the intervention and 8 weeks later at the end of the intervention
Method of measurement
Special laboratory kit
2
Description
TG
Timepoint
At the beginning of the intervention and 8 weeks later at the end of the intervention
Method of measurement
Special laboratory kit
3
Description
TC
Timepoint
At the beginning of the intervention and 8 weeks later at the end of the intervention
Method of measurement
Special laboratory kit
4
Description
LDL
Timepoint
At the beginning of the intervention and 8 weeks later at the end of the intervention
Method of measurement
Special laboratory kit
5
Description
HDL
Timepoint
At the beginning of the intervention and 8 weeks later at the end of the intervention
Method of measurement
Special laboratory kit
6
Description
FBS
Timepoint
At the beginning of the intervention and 8 weeks later at the end of the intervention
Method of measurement
Special laboratory kit
7
Description
HbA1c
Timepoint
At the beginning of the intervention and 8 weeks later at the end of the intervention
Method of measurement
Special laboratory kit
8
Description
hs-CRP
Timepoint
At the beginning of the intervention and 8 weeks later at the end of the intervention
Method of measurement
Special laboratory kit
Intervention groups
1
Description
Intervention group: They will receive 300g of probiotic yogurt(Haraz Company) enriched with Bifidobacterium lactis and Lactobacillus acidophilus strains daily for 8 weeks. Microbiological analyzes showed that the average colony content of both strains is 10 ^ 6 CFU / g.
Category
Rehabilitation
2
Description
Control group: Control group: 300g will receive normal yogurt from Haraz company for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Clinic of Imam Khomeini Hospital, Tehran
Full name of responsible person
Seyed Mojtaba Ghoreishy
Street address
Imam Khomeini Hospital, at the end of Keshavarz Boulevard, Dr. Gharib Street, Tehran, Tehran Province
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
Imamhospital@tums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mr. Dr. Sahraian
Street address
Vice Chancellor for Research and Technology, Central University Organization, sixth floor, corner of Quds Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
14155-6117
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Diabetes Research Center, Research Institute of Endocrinology and Metabolism, Tehran University of Medical Sciences
Proportion provided by this source
40
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
Tehran University of Medical Sciences
Full name of responsible person
Seyed Mojtaba Ghoreishy
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Dietetics, No. 44, Hojjatdoost Alley, Naderi St., Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
3913883361
Phone
+98 86 4222 8244
Fax
Email
seyed.mojtaba.ghoreishy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Mojtaba Ghoreishy
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Dietetics, No. 44, Hojjatdoost Alley, Naderi St., Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
3913883361
Phone
+98 86 4222 8244
Fax
Email
seyed.mojtaba.ghoreishy@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Mojtaba Ghoreishy
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Dietetics, No. 44, Hojjatdoost Alley, Naderi St., Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
3913883361
Phone
+98 86 4222 8244
Fax
Email
seyed.mojtaba.ghoreishy@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
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