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General information
2021-06-20, 1400/03/30
2021-08-21, 1400/05/30
2021-0608-2021 00:00:00
Due to corona virus pandemic, we had trouble in sampling, so we decided to postpone the date of sampling.
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.
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.
به دلیل پاندمی بیماری کرونا در نمونه گیری با مشکل مواجه شدیم و برآن شدیم تا تاریخ شروع نمونه گیری را به تعویق بیاندازیم.
به دلیل پاندمی بیماری کرونا در نمونه گیری با مشکل مواجه شدیم و برآن شدیم تا تاریخ شروع نمونه گیری را به تعویق بیاندازیم.
همچنین به دلیل همکاری پایین بیماران برای ورود به مطالعه برای وارد کردن تعداد کافی از آن ها نمونه گیری دو ماه دیگر نیز ادامه دارد.
به دلیل پاندمی بیماری کرونا در نمونه گیری با مشکل مواجه شدیم و برآن شدیم تا تاریخ شروع نمونه گیری را به تعویق بیاندازیم. همچنین به دلیل همکاری پایین بیماران برای ورود به مطالعه برای وارد کردن تعداد کافی از آن ها نمونه گیری دو ماه دیگر نیز ادامه دارد.
Protocol summary
Study aim
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
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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
Main outcome variables
hs-CRP; IL-6; IL-10; TNF-α; ESR; DAS-28; HAQ-DI
General information
Reason for update
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.
Acronym
IRCT registration information
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
Registration date
2021-02-14, 1399/11/26
Registrant information
Name
Farzaneh Asoudeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5522 1286
Email address
a.asodeh75@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-20, 1400/02/30
Expected recruitment end date
2021-08-21, 1400/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotic cheese on inflammatory and anti-inflammatory markers, disease severity and symptoms in patients with rheumatoid arthritis
Public title
The effect of probiotic cheese consumption on the improvement of patients with rheumatoid arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 20 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
14155-6117
Approval date
2020-12-12, 1399/09/22
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.883
Health conditions studied
1
Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M05
ICD-10 code description
Rheumatoid arthritis with rheumatoid factor
Primary outcomes
1
Description
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
Secondary outcomes
1
Description
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
2
Description
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)
3
Description
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
4
Description
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
5
Description
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
6
Description
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
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
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.