Protocol summary
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Study aim
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This study aims to investigate the effects of taking probiotics on the level of bacterial endotoxin in serum as the index of intestinal immune, the level of endotoxin in faeces sample and DNA damage of peripheral blood mononuclear lymphocytes in dialysis patients.
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Design
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A controlled, permuted block randomization clinical trial in 41 dialysis patients for 6 months.
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Settings and conduct
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This study will be conducted on the dialysis ward of Imam Hossein hospital. The patients who will sign informed consent will be divided into two groups. Demographic information will be collected using a demographic questionnaire through intervention and then five cc blood sample and faecal sample will be taken. The intervention will be begun by giving probiotics capsules to the participants for 6 months. At the end of the intervention, blood and faecal samples will be taken again.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: over 18 years of age, glomerular filtration rate less than 15 ml/min, having routine diets
Exclusion Criteria: infectious diseases, pregnancy (for female participants), autoimmune or immunosuppressive diseases, treatment with immunosuppressive drugs or antibiotics, lactose intolerance
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Intervention groups
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The intervention group: taking a probiotics capsule daily
The control group: taking no intervention
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Main outcome variables
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Serum endotoxin level, faecal endotoxin level, DNA damage in peripheral blood mononuclear lymphocytes
General information
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Reason for update
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to complete the information of the study
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2016103130603N1
Registration date:
2017-04-14, 1396/01/25
Registration timing:
prospective
Last update:
2020-01-29, 1398/11/09
Update count:
1
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Registration date
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2017-04-14, 1396/01/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for research, Shahroud University of Medical Sciences
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Expected recruitment start date
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2017-04-21, 1396/02/01
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Expected recruitment end date
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2017-12-22, 1396/10/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of probiotics on the serum level of endotoxin, the faecal levels of endotoxin and DNA damage in peripheral blood mononuclear lymphocytes of dialysis patients
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Public title
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The effect of probiotics on infectious disease and DNA damage in lymphocytes of dialysis patients
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
over 18 years of age, glomerular filtration rate less than 15 ml/min, having routine diets
Exclusion criteria:
infectious diseases, pregnancy (for female participants), autoimmune or immunosuppressive diseases, taking immunosuppressive drugs or antibiotics, lactose intolerance
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization assignment will be done based on sample size and permuted blocked method into four groups using computer-generated random numbers and written on closed envelopes. The participants who will sign informed consent will be divided into control or intervention groups. The allocation will be concealed from participants by closed envelopes.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-10-08, 1395/07/17
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Ethics committee reference number
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ir.shmu.rec.1395.113
Health conditions studied
1
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Description of health condition studied
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Chronic kidney disease
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ICD-10 code
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N18
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ICD-10 code description
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Chronic kidney disease
Primary outcomes
1
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Description
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Serum level of endotoxin
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Timepoint
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Before and after the intervention (6 months)
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Method of measurement
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Limulus Amebocyte Lysate (LAL) kit
2
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Description
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DNA Damage of peripheral blood mononuclear lymphocytes
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Timepoint
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Before and after the intervention (6 months)
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Method of measurement
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Comet Assay
3
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Description
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faecel level of endotoixn
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Timepoint
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Before and after the intervention (6 months)
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Method of measurement
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Limulus Amebocyte Lysate (LAL) kit
Intervention groups
1
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Description
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Intervention Group: taking probiotics capsule (4BioCap 180 mg) made by Tehran Daroo company Containing: Lactobacillus acidophilus, Bifidobacterium SPP, Streptococcus thermophilus, Lactobacillus delbrueckii bulgaricus, Dosage & Duration: 6 months, 1 capsule per day
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Category
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Treatment - Drugs
2
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Description
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Control group: taking no intervention
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahroud University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Serum level of endotoxin, faecal level of endotoxin and DNA damage of peripheral blood mononuclear lymphocytes
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When the data will become available and for how long
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After publishing the related article
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To whom data/document is available
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Researchers
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Under which criteria data/document could be used
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Without any condition
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From where data/document is obtainable
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Vice-Chancellor for Research, Shahroud University of Medical Sciences
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What processes are involved for a request to access data/document
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By sending a request email
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Comments
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