Protocol summary
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Study aim
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The aim of this study is to determine the effects of probiotic supplementation on metabolic profiles in patients with rheumatoid arthritis.
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Design
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Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers.
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Settings and conduct
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Population and sample size: 60 patients with rheumatoid arthritis of eligible and referred to internal medicine and rheumatology affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
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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: Chronic renal failure, renal tubular acidosis or pancreatitis, patients likely to be started on biological agents, pregnant or lactating women, patients who are unable to read numbers and/or unable to mark the pain scale, patients unlikely to come for follow-up in the following 3 months.
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Intervention groups
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Intervention: Patients will be assigned to receive either probiotic supplements (intervention group: n=30), placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 8-wk intervention. Start and end date of intervention: 2 months.
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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:
IRCT201511015623N58
Registration date:
2015-11-20, 1394/08/29
Registration timing:
retrospective
Last update:
2019-10-06, 1398/07/14
Update count:
1
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Registration date
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2015-11-20, 1394/08/29
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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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Kashan University of Medical Sciences
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Expected recruitment start date
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2015-09-29, 1394/07/07
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Expected recruitment end date
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2015-10-20, 1394/07/28
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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 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:
Chronic renal failure
Renal tubular acidosis or pancreatitis
Patients likely to be started on biological agents
Pregnant or lactating women
Patients who are unable to read numbers and/or unable to mark the pain scale
Patients unlikely to come for follow-up in the following 3 months
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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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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 probiotic supplements (n=30) or the standard diet (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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2015-09-28, 1394/07/06
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Ethics committee reference number
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IR.Kaums.REC.1394.82
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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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
3
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Description
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HDL-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
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 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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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
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 after 8 weeks of intervention
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Method of measurement
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Spectrophotometry
7
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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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Elisa kit
8
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Description
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Fasting blood sugar
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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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VLDL
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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
Intervention groups
1
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Description
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Intervention group: Probiotic capsule containing four strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g), daily, 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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Control group: Probiotic placebo capsule, daily, 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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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