Effect of Probiotics on elastographic findings of patients with nonalcoholic fatty liver diseas
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 70 patients. Patients were randomly divided 2 group by block randomization.
Settings and conduct
Participants will be selected from patients with non-alcoholic fatty liver disease referred to the gastrointestinal clinics of Imam Reza Hospital. General information of patients will be extracted using a questionnaire. All patients will also undergo elastography. first group will be given the drug Rifaximin 550 mg twice a day for a week in addition to their usual treatments. After a week, they will receive probiotic capsules twice a day for 6 months. The control group will also take a placebo drug in addition to Will receive their usual. After completing 6 months of treatment, patients will undergo elastography again and the degree of stasis and liver fibrosis will be determined based on LSM and CAP criteria. Pre- and post-intervention findings will be compared.
Participants/Inclusion and exclusion criteria
inclusive criteria; Age 18 to 59 years; No history of alcohol; Do not take drugs with liver toxicity
exclusive criteria ;liver disease with specific etiologies such as viral hepatitis; Cirrhosis;Pregnancy and lactation; Use nutritional supplements; antibiotic use
Intervention groups
case group studied after one week of probiotic capsules containing Lactobacillus rhamnosus, Bifidobacterium lactis, Lactobacillus casei, Bifidobacterium brove, Lactobacillus acidophilus, Bifidobacterium langum, Lactobacillus m. As a probiotic, they will receive 2 times a day for 6 months. And the control group will receive starch capsules with this pattern
Main outcome variables
Determination of the effect of probiotics on hepatic steatosis and fibrosis in patients with non-alcoholic fatty liver disease
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220104053626N1
Registration date:2022-01-11, 1400/10/21
Registration timing:retrospective
Last update:2022-01-11, 1400/10/21
Update count:0
Registration date
2022-01-11, 1400/10/21
Registrant information
Name
Masood Dinevari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
dinvarim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-28, 1399/12/10
Expected recruitment end date
2021-05-20, 1400/02/30
Actual recruitment start date
2021-04-30, 1400/02/10
Actual recruitment end date
2021-09-21, 1400/06/30
Trial completion date
2022-04-21, 1401/02/01
Scientific title
Effect of Probiotics on elastographic findings of patients with nonalcoholic fatty liver disease
Public title
The effect of probiotics on non-alcoholic fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 59 years
Willingness to participate in the study
No history of alcohol consumption
Do not take drugs with liver toxicity
Exclusion criteria:
Having liver disease with specific etiologies such as viral hepatitis
Cirrhosis of the liver
alcohol consumption
Pregnancy and lactation
Take other nutritional supplements
Recent 3 months of antibiotic use
Age
From 18 years old to 59 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
From the patients who volunteered to participate in the study, 70 persons will be selected by simple random sampling. Randomization method: Randomization unit block: Individual Randomization layers: In each block, people will be matched based on age and gender. Random Allocation software: Random Allocation software How to create a random sequence: Using Random Allocation software Hide: The random sequence created is kept in a safe place and is done by an independent person who is not involved in the experiment during the study. Random allocation of hidden individuals, patients and researchers will not be aware of it.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind study in which the researcher of this study and the patients participating in the study will be unaware of the type of supplement received. Supplements will be provided to patients by another person who has no role in completing the questionnaire and performing blood tests. Patients will also be informed of the existence of two types of supplements (probiotics and placebo) when obtaining consent, but will be unaware of which study groups they will be included in. Placebo capsules are similar in appearance, color, and size to probiotic capsules.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golgasht Ave., emamreza hospital., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5163996889
Approval date
2021-04-12, 1400/01/23
Ethics committee reference number
IR.TBZMED.REC.1400.072
Health conditions studied
1
Description of health condition studied
Patients with non-alcoholic fatty liver disease diagnosed with ultrasound findings
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Determination of the effect of probiotics on hepatic steatosis in patients with non-alcoholic fatty liver disease in comparison with the control group
Timepoint
After completing 6 months of treatment, patients will undergo elastography again and the degree of stasis will be determined based on LSM and CAP criteria. Pre- and post-intervention findings will be compared.
Method of measurement
After treatment, patients will undergo elastography again and the degree of stasis will be determined based on LSM and CAP criteria. Pre- and post-intervention findings will be compared.
2
Description
Determination of the effect of probiotics on hepatic fibrosis in patients with non-alcoholic fatty liver disease in comparison with the control group
Timepoint
After completing 6 months of treatment, patients undergo elastography again and the degree of their liver fibrosis will be determined based on LSM and CAP criteria. The findings before and after the intervention will be compared.
Method of measurement
After completing the treatment, the patients will undergo elastography again and their degree of liver fibrosis will be determined according to LSM and CAP criteria. The findings before and after the intervention will be compared.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to their usual medications, Rifaximin 550 mg tablets will be given twice a day for a week after one week of probiotics containing a combination of Lactobacillus rhamnosus, Bifidobacterium lactis, Lactobacillus casei, Bifidobacterium bruce, Lactobacillus acidophilus. , Bifidobacterium bifidum, Streptococcus thermophilus each will be in the amount (10 to the power of 9 CFU), as a probiotic will receive 2 times a day for 6 months Group
Category
Treatment - Drugs
2
Description
Control group: In addition to their usual medications, Rifaximin 550 mg tablets will be given twice a day for a week. After one week, they will receive the starch capsule as a medicine twice a day for 6 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Maryam Khalili
Street address
Golgasht Ave., Emam Reza hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5163996889
Phone
+98 41 3337 2084
Email
Maryam.khalili1305@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masoud Faghih Dinevari
Street address
Golgasht Ave., Emam Reza hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5164886994
Phone
+98 41 3337 2084
Email
masood.dinevari@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masood Dinevari
Position
Assisstant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Internal medicine department,Emam reza hospital,golgasht avenue,Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5164886994
Phone
+98 41 3334 7054
Fax
Email
dinvarim@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masoud Faghih Dinevari
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Golgasht Ave., Emamreza Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5174666994
Phone
+98 41 3337 2084
Email
masood.dinevari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masoud Faghih Dinevari
Position
asisstant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Golgast Ave., Emamreza hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5174666994
Phone
+98 41 3337 2084
Email
masood.dinevari@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only the results of the main outcome will be published in the form of an article
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
After the article is published, everyone will have access to the results
Under which criteria data/document could be used
After the article is published, everyone will have access to the results
From where data/document is obtainable
After the article is published, everyone will have access to the results
What processes are involved for a request to access data/document
After the article is published, everyone will have access to the results