Protocol summary
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Study aim
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The aim of this study is to determine the effects of synbiotic supplementation on metabolic profiles in patients with rheumatoid arthritis.
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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 synbiotic supplement (n=27) or placebo (n=27).
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Settings and conduct
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Among with rheumatoid arthritis patients referred to Shahid Beheshti Clinic, 54 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Fasting blood samples will be taken at baseline and 8 weeks after the intervention. At the beginning and the end of the intervention: 8 weeks.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with rheumatoid arthritis and aged 25 to 70 years.
Exclusion criteria: Patients who have chronic renal failure, pregnant or lactating women, symptoms or personal history of cardiovascular disease, diabetes mellitus, the consumption of antihyperglycemic agents, patients unlikely to come for follow-up in the following 3 months and patients who are unable to read numbers and/or unable to mark the pain scale, taking probiotics, synbiotics, antioxidant and/or anti-inflammatory supplements, taking antibiotics.
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Intervention groups
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Intervention group: Synbiotic supplements (Tak Gen Zist Pharmaceutical Company, Tehran, Iran), one capsule for 8 weeks orally. Control group: placebo (Tak Gen Zist Pharmaceutical Company, Tehran, Iran), one capsule for 8 weeks orally.
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Main outcome variables
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Outcomes: Inflammatory factors and DAS-28 (primary outcomes), markers of insulin metabolism, lipid profiles and biomarkers of oxidative stress (secondry outcomes) will be quantified at study baseline and end-of-trial.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201611165623N94
Registration date:
2016-11-18, 1395/08/28
Registration timing:
retrospective
Last update:
2019-09-14, 1398/06/23
Update count:
1
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Registration date
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2016-11-18, 1395/08/28
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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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2016-08-08, 1395/05/18
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Expected recruitment end date
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2016-09-08, 1395/06/18
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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 synbiotic supplementation compared with the placebo on metabolic profiles in patients with rheumatoid arthritis
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Public title
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Effect of supplementation in treatment of patients with rheumatoid arthritis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with rheumatoid arthritis
Aged 25 to 70 years
Exclusion criteria:
Patients who had chronic renal failure
Pregnant
Lactating women
Symptoms or personal history of cardiovascular disease, diabetes mellitus
The consumption of antihyperglycemic agents
Patients unlikely to come for follow-up in the following 3 months
Patients who are unable to read numbers and/or unable to mark the pain scale
Taking probiotics, synbiotics, antioxidant and/or anti-inflammatory supplements
Taking antibiotics
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Age
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From 25 years old to 70 years old
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Gender
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Both
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Phase
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2
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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:
54
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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 balanced randomisation, subjects will be allocated into two groups to receive supplement or placebo. 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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Random assignment will be done by the use of computer-generated random numbers.
Ethics committees
1
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Ethics committee
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Approval date
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2016-08-07, 1395/05/17
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Ethics committee reference number
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IR.Kaums.REC.1395.46
Health conditions studied
1
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Description of health condition studied
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Rheumatoid arthritis
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ICD-10 code
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M00.2
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ICD-10 code description
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Other streptococcal arthritis and polyarthritis
Primary outcomes
1
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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 after 8 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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Nitric oxide
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Spectrophotometry
3
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Description
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DAS-28
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Sum scores
Secondary 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 8 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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Total antioxidant
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Spectrophotometry
3
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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 after 8 weeks of intervention
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Method of measurement
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Spectrophotometry
4
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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 after 8 weeks of intervention
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Method of measurement
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Spectrophotometry
5
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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 after 8 weeks of intervention
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Method of measurement
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Enzymatic kit
6
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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 after 8 weeks of intervention
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Method of measurement
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Enzymatic kit
7
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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 after 8 weeks of intervention
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Method of measurement
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Enzymatic kit
8
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Description
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Fasting plasma glucose
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Enzymatic kit
9
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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 8 weeks of intervention
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Method of measurement
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Calculation using HOMA formula
Intervention groups
1
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Description
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Intervention group: Synbiotic capsule containing three strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g), and 0.8 g inulin (Tak Gen Zist, Tehran, Iran), once a day, for 8 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Conrol group: Placebo (Tak Gen Zist, Tehran, Iran), once a day, for 8 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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Not applicable
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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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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable