Protocol summary
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Study aim
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Objective: The aim of this study is to determine the effects of probiotic supplementation on metabolic profiles in patients with diabetic hemodialysis.
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Design
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Study design: randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive supplement (n=30) or placebo (n=30).
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Settings and conduct
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Among diabetic hemodialysis patients referred to Akhavan Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with diabetic hemodialysis aged 18 to 80 years.
Exclusion criteria: Pregnant women, intestinal diseases, taking probiotic supplements and other forms of probiotics including probiotic yogurt, kefir and other fermented foods, taking prebiotic, antioxidant and/or anti-inflammatory supplements such as vitamin E, vitamin C and omega-3 fatty acids, taking antibiotics, immunosuppressive medications within 3 months prior to the enrollment in the study.
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Intervention groups
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Intervention group: Probiotic supplements containing three strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g), daily, for 12 weeks orally.Control group: Placebo, daily, for 12 weeks orally.
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Main outcome variables
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Outcomes: Glycemic control (primary outcomes), and lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
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Reason for update
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Due to an error, the request for an update in our website was conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201603185623N69
Registration date:
2016-03-23, 1395/01/04
Registration timing:
retrospective
Last update:
2019-10-28, 1398/08/06
Update count:
1
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Registration date
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2016-03-23, 1395/01/04
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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, Kashan University of Medical Sciences
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Expected recruitment start date
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2016-02-29, 1394/12/10
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Expected recruitment end date
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2016-03-10, 1394/12/20
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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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Clinical trial of the effect of probiotic supplementation compared with the placebo on metabolic profiles in patients with diabetic hemodialysis
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Public title
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Effect of supplementation in treatment of patients with diabetic hemodialysis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Inclusion criteria: Patients with diabetic hemodialysis aged 18 to 80 years.
Exclusion criteria:
Pregnant women
Intestinal diseases
Taking probiotic supplements and other forms of probiotics including probiotic yogurt, kefir and other fermented foods
Taking prebiotic, antioxidant and/or anti-inflammatory supplements such as vitamin E, vitamin C and omega-3 fatty acids
Taking antibiotics, immunosuppressive medications within 3 months prior to the enrollment in the study
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Age
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From 18 years old to 80 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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- Participant
- Investigator
- Outcome assessor
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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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At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take supplementation (n=30) or placebo (n=30). Randomization will be done by the use of computer-generated random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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Placebo
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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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2016-03-09, 1394/12/19
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Ethics committee reference number
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IR.Kaums.REC.1394.166
Health conditions studied
1
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Description of health condition studied
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همودیالیز
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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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Insulin
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa kit
2
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Description
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Insulin resistance
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Calcution using HOMA formula
Secondary outcomes
1
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Description
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Triglycerides
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Timepoint
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At the beginning of the study and 12 weeks after the intervention
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Method of measurement
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Enzymatic kit
2
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Description
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Total cholesterol
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Timepoint
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At the beginning of the study and 12 weeks after the intervention
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Method of measurement
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Enzymatic kit
3
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Description
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HDL
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Timepoint
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At the beginning of the study and 12 weeks after the intervention
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Method of measurement
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Enzymatic kit
4
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Description
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Total antioxidant
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Timepoint
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At the beginning of the study and 12 weeks after the intervention
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Method of measurement
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Spectrophotometry
5
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Description
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Glutathione
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Timepoint
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At the beginning of the study and 12 weeks after the intervention
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Method of measurement
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Spectrophotometry
6
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Description
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Malondialdehyde
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Timepoint
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At the beginning of the study and 12 weeks after the intervention
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Method of measurement
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Spectrophotometry
7
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Description
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Nitric oxide
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Timepoint
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At the beginning of the study and 12 weeks after the intervention
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Method of measurement
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Spectrophotometry
8
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Description
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Hs-CRP
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Timepoint
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At the beginning of the study and 12 weeks after the intervention
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Method of measurement
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Elisa kit
9
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Description
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Creatinine
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Timepoint
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At the beginning of the study and 12 weeks after the intervention
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Method of measurement
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Enzymatic kit
10
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Description
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BUN
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Timepoint
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At the beginning of the study and 12 weeks after the intervention
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Method of measurement
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Enzymatic kit
11
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Description
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Albumin
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Timepoint
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At the beginning of the study and 12 weeks after the intervention
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Method of measurement
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Enzymatic kit
12
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Description
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TIBC
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Timepoint
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At the beginning of the study and 12 weeks after the intervention
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Method of measurement
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Enzymatic kit
13
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Description
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LDL
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Timepoint
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At the beginning of the study and 12 weeks after the intervention
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Method of measurement
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Enzymatic kit
14
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Description
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VLDL
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Timepoint
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At the beginning of the study and 12 weeks after the intervention
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Method of measurement
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Enzymatic kit
15
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Description
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Sodium
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Timepoint
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At the beginning of the study and 12 weeks after the intervention
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Method of measurement
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Flame photometry
16
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Description
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Potassium
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Timepoint
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At the beginning of the study and 12 weeks after the intervention
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Method of measurement
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Flame photometry
17
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Description
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Hemoglobin A1c
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Timepoint
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At the beginning of the study and 12 weeks after the intervention
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Method of measurement
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Glycomat kit
Intervention groups
1
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Description
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Intervention group: Probiotic supplements containing three strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g), daily, for 12 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo, daily, for 12 weeks orally.
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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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Vice chancellor for research, Kashan 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available