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Evaluation of the effect of probiotic supplementation on the improvement of proteinuria in patients with immunoglobulin A nephropathy

Protocol summary

Study aim
Evaluation of the effect of probiotic supplementation on the improvement of proteinuria in patients with immunoglobulin A nephropathy
Design
This clinical trial was performed on 120 patients, divided into two groups of 60, including a control group and parallel groups. This study is Double-blind and block randomization method is used.
Settings and conduct
All supplements and placebo capsules were identical with respect to appearance and only differed in coding of the capsules. The treatment code of the intervention supplements was blinded for subjects, investigators and staff involved in the conduct of the study.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age over 18 years, Early IgA nephropathy diagnosed by biopsy, Albuminuria more than 0.75 grams per day, Serum creatinine less than 200 micromoles per liter, Creatinine clearance greater than 30 ml per minute Exclusion Criteria: Inflammatory diseases, Diabetes, Celiac, Cancer, AIDS, Autoimmune diseases, Pregnancy, Breastfeeding, Secondary IgA nephropathy, Allergy to probiotics
Intervention groups
Patients in the intervention group, in addition to standard treatment (omega 3 capsules 1000 mg and valsartan), receive probiotic capsules once a day for six months, and the control group also receive a placebo according to the above method.
Main outcome variables
Body Mass Index (BMI), 24-hour urinary protein level, Duration of illness, side effects

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190415043279N11
Registration date: 2022-03-07, 1400/12/16
Registration timing: prospective

Last update: 2022-03-07, 1400/12/16
Update count: 0
Registration date
2022-03-07, 1400/12/16
Registrant information
Name
Pezhman Sharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3324 9435
Email address
p.sharifi@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2022-10-07, 1401/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of probiotic supplementation on the improvement of proteinuria in patients with immunoglobulin A nephropathy
Public title
Evaluation of the effect of probiotic supplementation on the proteinuria
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years Early IgA nephropathy diagnosed by biopsy Albuminuria more than 0.75 grams per day Serum creatinine less than 200 micromoles per liter Creatinine clearance greater than 30 ml per minute
Exclusion criteria:
Inflammatory diseases Diabetes Celiac Cancer AIDS Autoimmune diseases Pregnancy Breastfeeding Secondary IgA nephropathy Allergy to probiotics
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Data analyser
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Using block randomization method with a block size of 4. Sampling method at this study will be according to random allocation. Participants will enter the study according to inclusion criteria, and then will be divided into two groups according to randomization table. One group will receive Probiotic Capsule and the other will receive placebo. The participants and administrator do not have any information about content of capsules (double blinded study). The list of randomization was computer-generated. supplements and placebo capsules were placed in completely identical packages and were coded by someone who was unaware of the nature of the study in numbered bottles based on the list. And another person who was unaware of the contents of the pack provided them to the patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
All supplements and placebo capsules were identical with respect to appearance and only differed in coding of the capsules. The treatment code of the intervention supplements was blinded for subjects, investigators and staff involved in the conduct of the study.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Vice Chancellor for research of Kurdistan University of Medical Sciences, Pasdaran Blvd, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Approval date
2021-12-21, 1400/09/30
Ethics committee reference number
IR.MUK.REC.1400.255

Health conditions studied

1

Description of health condition studied
IgA nephropathy
ICD-10 code
E08.21
ICD-10 code description
Diabetes mellitus due to underlying condition with diabetic nephropathy

Primary outcomes

1

Description
Body Mass Index (BMI)
Timepoint
At the beginning of the study (before the intervention) and after the intervention
Method of measurement
by measuring height and weight using a scale and height meter

2

Description
24-hour urinary protein level
Timepoint
At the beginning of the study (before the intervention) and after the intervention
Method of measurement
laboratory kit

3

Description
Duration of illness
Timepoint
Examination by a nephrologist once every two months until the end of the 6-month period (three times)
Method of measurement
Patient file

4

Description
side effects
Timepoint
Periodically every month until the end of 6 months
Method of measurement
Telephone contact with patients

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Omega 3 capsules 1000 mg and Valsartan in addition to probiotic capsules of Milad Pouya Company Probiotic Capsules, approved by the US Food and Drug Administration and under the brand name Prodigest, are taken once a day for six months.
Category
Placebo

2

Description
Control group: Omega 3 capsules 1000 mg, Valsartan plus placebo are taken as one capsule once a day for six months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Nephrology Clinic of Tohid Hospital
Full name of responsible person
Dr. Mohammad Saad Forghani
Street address
Tohid Hospital, Geriashan Ave
City
Sanandaj
Province
Kurdistan
Postal code
6616812131
Phone
+98 87 3366 4645
Email
drforghani7791@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Dr. Afshin Maleki
Street address
Vice Chancellor for research of Kurdistan University of Medical Sciences, Pasdaran Blvd, Sanandaj, Iran.
City
Sanandaj
Province
Kurdistan
Postal code
6617713466
Phone
+98 87 3366 4645
Email
maleki43@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Dr Mohammad saad Forghani
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Tohid Hospital, Tohid Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4645
Email
drforghani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Dr Mohammad saad Forghani
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Tohid Hospital, Tohid Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4645
Email
drforghani7791@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Pezhman Sharifi
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Microbiology
Street address
Research Department, Tohid Hospital, Tohid Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617713466
Phone
+98 87 3324 9435
Fax
+98 87 3324 9435
Email
p.sharifi@muk.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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