Protocol summary
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Study aim
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Investigating the treatment of probiotics on the progression of NAFLD in patients with non-alcoholic fatty liver disease
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Design
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A trial with a control group. Three blinded, randomized strains. phase on 120 patients. The block method will be used as a method that leads to balanced allocation of people in treatment groups at the end of each block. For this purpose, the website https://www.sealedenvelope.com/simple-randomiser/v1/lists is used.
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Settings and conduct
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120 cases with ages from 20 to 75 with fatty liver confirmed in Persian cohort of Mashhad in three-way blind method which the patient and the researcher analyzing the data are unaware, randomly assigned to two groups.
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Participants/Inclusion and exclusion criteria
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Criteria for entering the study:
Healthy people between the ages of 20 and 75 with confirmed fatty liver in Persian cohort of Mashhad
Exclusion criteria:
Liver failure
Getting hepatitis (viral, autoimmune, metabolic, drug)
History of alcohol using
People with ALT or AST more than 5 times normal
Pregnant women
Taking drugs that can cause hepatic steatosis
Use of blood pressure lowering drugs (Vastatins)
Known hereditary defects (iron and copper).
storage diseases and alpha 1 antitrypsin deficiency)
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Intervention groups
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The study group is treated with one pill per day containing 500 million Lactobacillus bulgaricus and Streptococcus thermophilus and the control group is treated with a placebo pill (120 mg of starch). Each patient received a total of 90 tablets in the manner of taking one tablet daily. After 3 months, all the tests including ultrasound of the liver are performing in the same way for both groups.
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Main outcome variables
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weight,
blood pressure, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, LFT (ALT/AST, ALP), bilirubin
Anthropometric data
General information
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Reason for update
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Removal of fibroscan from the work procedure due to lack of budget approval
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20231229060558N1
Registration date:
2024-05-16, 1403/02/27
Registration timing:
prospective
Last update:
2025-03-21, 1404/01/01
Update count:
1
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Registration date
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2024-05-16, 1403/02/27
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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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2024-05-21, 1403/03/01
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Expected recruitment end date
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2025-03-19, 1403/12/29
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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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Evaluation of the efficacy of probiotics in Nonalcoholic Fatty Liver Disease treatmenth
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Public title
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Effect of probiotics in Nonalcoholic Fatty Liver
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
People between 20 and 75 years old with confirmed fatty liver in Persian Cohort of Mashhad
Exclusion criteria:
•Liver failure
• Suffering from hepatitis (viral, autoimmune, metabolic, medicinal)
• History of alcohol consumption
• People with ALT or AST more than 5 times normal •
• Pregnant people
•Taking drugs that can cause hepatic steatosis, including antiarrhythmic drugs (Amiodarone) ), anti-metabolite antineoplastic drugs (methotrexate), hormonal antineoplastic drugs (tamoxifen), corticosteroids, anticonvulsant drugs, antiretroviral drugs
• use of antihypertensive drugs, vastatins)
• known hereditary defects (iron and copper). Storage diseases and alpha 1 antitrypsin deficiency
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Age
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From 20 years old to 75 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
- Data analyser
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Sample size
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Target sample size:
120
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In order to assigning people randomly to the study groups while ensuring the equality of the sample size of the groups, the block method will be used as a reliable method of randomization that leads to the balanced allocation of people in the treatment groups at the end of each block. For this purpose, the website https://www.sealedenvelope.com/simple-randomiser/v1/lists is used. In this study, the size of the blocks is 4, 6, and 8, and a total of 19 blocks consisting of 5 blocks of 4, 4 blocks of 6, and 10 blocks of 8 with different sequences are formed from both arms of the study at the exit of the site. Next, each of the blocks is sealed in a non-transparent sealed envelope and all the blocks are randomly arranged. With the referral of each eligible patient, the first block is randomly selected and depending on the order of the sequence, the desired person is placed in one of the arms of the study. In the same way, after the completion of the first block, the second block is randomly selected and this continues until the last block and assigning the last person to the study arms. As a rule, by assigning the last sheet of the last block, the patients are grouped equally in the two arms of the study and the balance between the groups is established.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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Three direction blinding: blinding (subjects under study, evaluator, analysts, allocator of samples to groups) for randomly assigning people to study groups while ensuring equal sample size of the groups using the block method as a reliable method of randomization that leads to Balanced allocation of people in treatment groups will be used at the end of each block. Each block is shielded in a non-transparent closed envelope and all blocks are arranged randomly. With the referral of each eligible patient, the first block is randomly selected and depending on the order of the sequence, the desired person is placed in one of the arms of the study.
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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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2024-01-02, 1402/10/12
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Ethics committee reference number
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IR.MUMS.MEDICAL.REC.1402.482
Health conditions studied
1
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Description of health condition studied
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Nonalcoholic Fatty Liver
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ICD-10 code
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K76.0
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ICD-10 code description
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Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
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Description
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The percentage of people with non-alcoholic fatty liver disease with a score of at least 2
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Timepoint
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Examining tests three months after start of using probiotics
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Method of measurement
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Liver tests including sugar and fat profile, ultrasound of the liver and bile ducts
Intervention groups
1
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Description
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Intervention group: one pill per day containing 500 million Lactobacillus bulgaricus and Streptococcus thermophilus (Nutricion Medica, SL, Spain) with the brand name Lactofer of bio-fermenting company. And each patient is recievung a total of 90 pills by taking one pill daily. Patients are followed up monthly by the plan supervisor. After three months again, all the tests, ultrasound of the liver and bile ducts are performed in the same way and the data are analyzed.
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Category
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Treatment - Drugs
2
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Description
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Control group: a placebo tablet made by Bio Fermentation Company, completely similar to the original drug on a daily basis. And each patient is receiving a total of 90 tablets in the manner of taking one tablet daily. Patients are followed up monthly by the plan supervisor. After three months again, all the tests, ultrasound of the liver and bile ducts are performed in the same way and the data are analyzed.
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Category
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Placebo
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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Mashhad 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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Yes - There is 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
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Title and more details about the data/document
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Only part of the data related to the main outcome can be shared.
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When the data will become available and for how long
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From year 2025
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To whom data/document is available
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Only for researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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In order to conduct additional research by citing the source
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From where data/document is obtainable
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Mashhad University of Medical Siences
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What processes are involved for a request to access data/document
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Refer to Mashhad University of Medical Sciences and contact the research department
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Comments
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