Protocol summary

Study aim
Determining the effect of synbiotic supplementation on fatigue and sleep quality in hemodialysis patients.
Design
Clinical trial with control group with parallel, double-blind, randomized, phase 3 groups on 60 patients. For randomization, 15 blocks of 4 permutations were used.
Settings and conduct
Among the patients referred to the dialysis ward of Musa Bin Jafar Hospital in Quchan, 60 patients will be selected based on inclusion and exclusion criteria. Participants and staff of the dialysis and data analysis department are unaware of the allocation of study groups. Supplemental capsules and placebo are similar in shape and size. At the beginning of the study, after obtaining written consent from all individuals, patients are randomly assigned to one of two groups receiving a synbiotic supplement or placebo. Patients should take the capsules twice daily with lunch and dinner during the 8 weeks of the intervention. Week 4 and the end of the study will be completed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18 and 65 years, a patient with a diagnosis of chronic renal failure who has been on hemodialysis for at least 3 months Exclusion criteria: Active infection during the last 30 days, use of antibiotics, prebiotics, probiotics, synbiotics, vitamin supplements or antioxidants during the last 30 days
Intervention groups
Intervention group: Synbiotic lactoker 500 mg diet supplement (manufactured by Iran Bio Fermentation Company) contains high amounts of 12 beneficial bacterial strains along with fructooligosaccharide as a pre-biotic. Control group: Capsules containing corn starch with a synbiotic-like appearance
Main outcome variables
Fatigue and sleep quality of patients with chronic kidney disease treated with hemodialysis

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210117050055N1
Registration date: 2021-02-21, 1399/12/03
Registration timing: prospective

Last update: 2021-02-21, 1399/12/03
Update count: 0
Registration date
2021-02-21, 1399/12/03
Registrant information
Name
Mina Jangpoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 8302
Email address
jangpoorm@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-06-05, 1400/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of synbiotics supplement on fatigue and sleep quality in hemodialysis patients with chronic kidney disease
Public title
Effect of synbiotics supplement on fatigue and sleep quality in hemodialysis patients with chronic kidney disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
A patient with a diagnosis of chronic kidney disease who undergoing hemodialysis for at least 3 months. signing informed consent for participation in the study Patient with arteriovenous fistula or permanent catheter or venous arterial graft The patient undergoing hemodialysis 3 times a week for 4 hours each time Patient with KT / V> 1 Do not suffer from hearing and vision disorders No neurological disorders and a history of hospitalization in the psychiatric ward age range of 18 to 65 years
Exclusion criteria:
Active infection during the last 30 days Pregnant or lactating mothers Taking antibiotics, prebiotics, probiotics, synbiotics, vitamin supplements or antioxidants during the last 30 days Suffering from autoimmune diseases or connective tissue disorders History of cardiovascular diseases Diabetic foot infection Gastrointestinal diseases (inflammatory bowel disease, ulcerative colitis, Crohn's disease, celiac disease, lactose intolerance or allergy, irritable bowel syndrome) Liver disease (such as hepatitis B, hepatitis C) suffering from various types of malignancies Smoking more than 10 cigarettes per day Participate in other drug interventions hemoglobin less than 8 mg/dl PSQI score less than 6 (good sleep quality) acquisition of CFS score less than 18
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method in this study is based on quadratic blocks. Thus, fifteen blocks of four are formed and inside each block, two people are considered as intervention and two people as control. They will be in the control (receiving placebo) and intervention (receiving synbiotic supplement) groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and staff in the dialysis and data analysis department are unaware of the allocation of study groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar University of Medical Sciences
Street address
No. 31, Towhid shahr Ave, Shohada Gomnam Blvd, campus of Sabzevar University of Medical Sciences, sabzevar
City
sabzevar
Province
Razavi Khorasan
Postal code
9617913112- صندوق 31
Approval date
2021-01-13, 1399/10/24
Ethics committee reference number
IR.MEDSAB.REC.1399.163

Health conditions studied

1

Description of health condition studied
chronic kidney disease
ICD-10 code
N18.4
ICD-10 code description
Chronic kidney disease, stage 4 (severe)

Primary outcomes

1

Description
fatigue
Timepoint
2 months
Method of measurement
Chalders Fatigue Scale

2

Description
Sleep quality
Timepoint
2 months
Method of measurement
Pittsburgh Sleep Quality Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention: Recipient of Lactococare synbiotic dietary supplement capsule (500 mg) containing 12 beneficial bacterial(Lactobacillus rhamnosus, Lactobacillus holoticus, Lactobacillus casei, Bifidobacterium lactis, Lactobacillus acidophilus, Bifidobacterium brochus, Lactobacillus bulgaricus, Bifidobacterium langobacum, Lactobacillus, Lactobacillus) strains with fructooligosaccharide as prebiotic (Made by Zist Tahkmir Iran Company)
Category
Treatment - Other

2

Description
Control group: Control group: receiving placebo capsules containing corn starch (500 mg) with a similar appearance to synbiotic capsules (Made by Zist Tahkmir Iran Company)
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Dialysis ward of Musabne Jafar Hospital in Quchan city under the supervision of Mashhad University
Full name of responsible person
Shadi Pur Abbas
Street address
Imam Khomeini Ave
City
Quchan
Province
Razavi Khorasan
Postal code
1234567891
Phone
+98 58 3241 2995
Email
Shahriarsshh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Fereshteh Qarat
Street address
No. 31, Towhid shahr Ave, Shohada Gomnam Blvd, campus of Sabzevar University of Medical Sciences, sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8300
Fax
Email
vcResearch@medsab.ac.ir
Web page address
https://www.medsab.ac.ir/index.aspx?fkeyid=&siteid=1&fkeyid=&siteid=1&pageid=8659
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Mina Jangpoor
Position
Master student of critical care nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 31, Towhid shahr Ave, Shohada Gomnam Blvd, campus of Sabzevar University of Medical Sciences, sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8300
Email
mina.jangpoor@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Ali Asghar Jasmi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No.31, Towhid shahr Ave, Shohada Gomnam Blvd, campus of Sabzevar University of Medical Sciences, sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8300
Email
jesmiaa@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mina Jangpoor
Position
Master student of critical care nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.31,Towhid shahr Ave, Shohada Gomnam Blvd, campus of Sabzevar University of Medical Sciences, sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8300
Email
mina.jangpoor@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
Information on fatigue and sleep quality will be published in connection with the use of synbiotic supplements
When the data will become available and for how long
one year after the publication date
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Do not use the submitted data to print articles.
From where data/document is obtainable
Dr. Ali Asghar Jasmi. Email jesmiaa@gmail.com Phone:5144018300پس از
What processes are involved for a request to access data/document
The request will be submitted to the supervisor Dr. Ali Asghar Jasmi and his approval and registration in the Secretariat of Documents or Files.
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