Protocol summary
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Study aim
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The main objective of the project:
Determining the effect of probiotic cheese consumption on inflammatory, anti-inflammatory factors, symptoms and severity of the disease in patients with rheumatoid arthritis
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Design
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A parallel randomized clinical trial with a sample size of 40 in the present study . participants will be stratified into different blocks. For each patient in a certain block, a matched person in terms of above mentioned variables would be placed in that block. Then, these two patients in a given block would be randomly assigned to the intervention and control groups.
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Settings and conduct
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Sampling for this study will be done based on the inclusion criteria in Rheumatology center in Shariati Hospital in Tehran. After selecting the participants, individuals will be divided into two groups of intervention and control based on random allocation. People in the intervention and control groups will be advised to consume 30 grams of cheese given to them daily for 12 weeks. In this double-blind study, the researcher and the participant who consuming the cheese are unaware of type of cheese. So a person out of study will distribute cheeses.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria
1. Women 20 to 60 years old with moderate to severe rheumatoid arthritis
Exclusion criteria
1. Having other inflammatory diseases
2. Being pregnant or breastfeeding
3. dietary supplements consumption at least one month before the intervention
4. Receive antibiotics within 1 month before the intervention
5. Consumption of probiotic foods during the last month
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Intervention groups
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Participants in intervention group should receive 30 grams of probiotic cheese daily
Participants in control group should daily receive 30 grams of cheese without probiotic with a similar appearance and taste to intervention group cheese
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Main outcome variables
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hs-CRP; IL-6; IL-10; TNF-α; ESR; DAS-28; HAQ-DI
General information
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Reason for update
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Due to corona virus pandemic, we had trouble in sampling, so we decided to postpone the date of sampling.
Also, due to the low cooperation of patients to enter the study to enter sampling continues for another two months.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20201120049449N1
Registration date:
2021-02-14, 1399/11/26
Registration timing:
prospective
Last update:
2021-06-22, 1400/04/01
Update count:
2
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Registration date
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2021-02-14, 1399/11/26
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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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Expected recruitment start date
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2021-05-20, 1400/02/30
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Expected recruitment end date
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2021-08-21, 1400/05/30
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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 probiotic cheese on inflammatory and anti-inflammatory markers, disease severity and symptoms in patients with rheumatoid arthritis
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Public title
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The effect of probiotic cheese consumption on the improvement 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:
Subjects with mild to moderate RA diagnosed by a rheumatologist using the ACR (American College of Rheumatology) criteria
Women aged 20–60 years
Following stable drug therapy At least in the last three months
BMI 25–40 kg/m2
Exclusion criteria:
Suffered from other inflammatory diseases including pancreatitis, IBD and myocarditis
Pregnant or breastfeeding
Tobacco or drug use
Alcoholic beverages consumption
Liver or kidney disorder
Gastrointestinal disorders or lactose intolerance
Dietary supplements consumption at least one month before the intervention
Using antibiotics one month before the intervention
Follow a weight loss diet over the past month
Consumption of probiotic foods during the last month
Acute heart disease
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Age
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From 20 years old to 60 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Participants will be stratified based on age (20 to 40 and 40 to 60 years), BMI (<30 and≥30 kg / m2), and type of medicines (NSAIDs / DMARDs / steroids / immunosuppressive) into different blocks and will be randomly allocated to the intervention or control groups. For each patient in a certain block, a matched person in terms of above mentioned variables would be placed in that block. Then, these two patients in a given block would be randomly assigned to the intervention and control groups. To do randomization, an identification code will be given to each eligible patient, and then, code of patients with the same age, BMI, and medication will be stated in the lottery container, and finally, patients with the same conditions will be randomly assigned to the intervention or control groups. Random allocation will be done by a person who is unaware about the aim of our study.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The researcher and participant are unaware of the type of cheese (probiotic or simple) and only the distributor is aware of the type of cheese.
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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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2020-12-12, 1399/09/22
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1399.883
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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M05
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ICD-10 code description
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Rheumatoid arthritis with rheumatoid factor
Primary outcomes
1
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Description
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Serum level of high-sensitivity C-reactive protein (High-sensitivity C-reactive protein is an acute-phase protein that produced by the liver in response to inflammation)
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Timepoint
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At the beginning of the study (before the intervention) and at the end of the study (84 days after the start)
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Method of measurement
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Using a special commercial kit
Secondary outcomes
1
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Description
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The severity of disease assessment
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Timepoint
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At the beginning of the study (before the intervention) and at the end of the study (84 days after the intervention)
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Method of measurement
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Das-28 questionnaire
2
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Description
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Assessment of disability related disease
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Timepoint
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At the beginning of the study (before the intervention) and at the end of the study (84 days after the intervention)
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Method of measurement
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HAQ-DI ( health assessment questionnaire-disability index)
3
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Description
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Serum level of Interleukin 6 (Interleukin 6 is an endogenous chemical which is active in inflammation, and in B cells maturation)
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Timepoint
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At the beginning of the study (before the intervention) and at the end of the study (84 days after the start)
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Method of measurement
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Using a special commercial kit
4
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Description
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Serum level of Interleukin 10 (Interleukin 10 is an anti-inflammatory cytokine also known as human cytokine synthesis inhibitory factor (CSIF))
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Timepoint
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At the beginning of the study (before the intervention) and at the end of the study (84 days after the start)
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Method of measurement
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Using a special commercial kit
5
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Description
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Serum level of Tumor necrosis factor alpha (Tumor necrosis factor alpha is is an inflammatory cytokine produced by macrophages/monocytes during acute inflammation and is responsible for a diverse range of signalling events within cells, leading to necrosis or apoptosis)
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Timepoint
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At the beginning of the study (before the intervention) and at the end of the study (84 days after the start)
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Method of measurement
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Using a special commercial kit
6
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Description
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Serum level of erythrocyte sedimentation rate ( Erythrocyte sedimentation rate is a type of blood test that measures how quickly erythrocytes settle at the bottom of a test tube that contains a blood sample and indirectly measures the degree of inflammation present in the body)
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Timepoint
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At the beginning of the study (before the intervention) and at the end of the study (84 days after the start)
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Method of measurement
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Using a special commercial kit
Intervention groups
1
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Description
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Intervention group: 30 grams of low-salt and low-fat probiotic cheese of Pegah Company daily for 12 weeks. Once every three weeks, enough packages of probiotic cheese will be distributed among the people in the intervention group.
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Category
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Treatment - Other
2
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Description
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Control group: 30 grams of low-salt and low-fat cheese without probiotic of Pegah Company daily for 12 weeks. Once every three weeks, enough packages of cheese will be distributed among the people in the intervention group.
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Category
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Treatment - Other
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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Tehran University of Medical Sciences
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Proportion provided by this source
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50
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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
2
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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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Tehran University of Medical Sciences
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Proportion provided by this source
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50
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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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Yes - There is 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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Yes - There is 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
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Title and more details about the data/document
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When the data will become available and for how long
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To whom data/document is available
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Under which criteria data/document could be used
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From where data/document is obtainable
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What processes are involved for a request to access data/document
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Comments
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