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IRCT20201120049449N1 IRCT 2021-02-14 Tehran University of Medical Sciences The effect of probiotic cheese consumption on the improvement of patients with rheumatoid arthritis The effect of probiotic cheese on inflammatory and anti-inflammatory markers, disease severity and symptoms in patients with rheumatoid arthritis 2021-05-20 anticipated 40 Complete https://irct.ir/trial/52436 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. N/A Rheumatoid arthritis. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is -
public Farzaneh Asoudeh
No.44, Hojjat doost Ave., Naderi St., Keshavarz Blvd., Tehran
Tehran Iran (Islamic Republic of) 14155-6117 +98 21 8895 5805 a.asodeh75@gmail.com Tehran University of Medical Sciences scientific Ahmad Esmaillzadeh
No. 44, Hojjat doost Ave., Naderi St., Keshavarz Blvd., Tehran
Tehran Iran (Islamic Republic of) 14155-6117 +98 21 8895 5805 a.esmaillzadeh@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) 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 20 years 60 years Female 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 M05 Rheumatoid arthritis with rheumatoid factor Treatment - Other Treatment - Other 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. 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. 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). Timepoint: At the beginning of the study (before the intervention) and at the end of the study (84 days after the start). Method of measurement: Using a special commercial kit. The severity of disease assessment. Timepoint: At the beginning of the study (before the intervention) and at the end of the study (84 days after the intervention). Method of measurement: Das-28 questionnaire. Assessment of disability related disease. Timepoint: At the beginning of the study (before the intervention) and at the end of the study (84 days after the intervention). Method of measurement: HAQ-DI ( health assessment questionnaire-disability index). Serum level of Interleukin 6 (Interleukin 6 is an endogenous chemical which is active in inflammation, and in B cells maturation). Timepoint: At the beginning of the study (before the intervention) and at the end of the study (84 days after the start). Method of measurement: Using a special commercial kit. Serum level of Interleukin 10 (Interleukin 10 is an anti-inflammatory cytokine also known as human cytokine synthesis inhibitory factor (CSIF)). Timepoint: At the beginning of the study (before the intervention) and at the end of the study (84 days after the start). Method of measurement: Using a special commercial kit. 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). Timepoint: At the beginning of the study (before the intervention) and at the end of the study (84 days after the start). Method of measurement: Using a special commercial kit. 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). Timepoint: At the beginning of the study (before the intervention) and at the end of the study (84 days after the start). Method of measurement: Using a special commercial kit. Tehran University of Medical Sciences Tehran University of Medical Sciences Tehran University of Medical Sciences Approved 2020-12-12 Ethics committee of Tehran University of Medical Sciences Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)