Effects of Probiotic on IL6 and TNF-a levels on patients with nonalcoholic fatty liver disease
Design
This study is a randomized, double-blind clinical trial with parallel groups and a control group that will be performed with the participation of 80 patients with fatty liver; Patients will be divided into intervention and control groups by block randomization
Settings and conduct
This clinical trial study will be performed with the participation of 80 patients with fatty liver disease referred to gastrointestinal clinics in Imam Reza Hospital (Tabriz Medical Sciences). ,IL6 and TNF-a level will be checked in initiation of study in all patients.first group will recieve probiotic capsules for 3 month.after completing 3 month ,IL6 and TNF-a level will be checked again and results will be compared pre and post intervention.researchers and patient and data analyzer will be blind in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: Age at 18-75 year,no history of alcohol consumption,Grade 2 in terms of fatty liver grading and willingness to participate in the study, and exclusion criteria also include: taking drugs with liver toxicity, history of antibiotic use in the last 3 months and liver disease with known etiology,such as viral hepatitis,Cirrhosis,pregnancy and lactation
Intervention groups
This study will be a randomized, double -blind clinical trial with parallel groups; 80 people will be randomly divided into two groups. Patients in the intervention group will take probiotic pills for three months and after three months, their IL6 and TNF levels will be measured; The control group will receive placebo.
Main outcome variables
Interleukin 6 and TNF-a secretion level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220104053626N3
Registration date:2022-02-22, 1400/12/03
Registration timing:prospective
Last update:2022-02-22, 1400/12/03
Update count:0
Registration date
2022-02-22, 1400/12/03
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
2022-03-16, 1400/12/25
Expected recruitment end date
2022-06-15, 1401/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Probiotic on IL6 and TNF-a levels on patients with nonalcoholic fatty liver disease
Public title
The effect of probiotics in patients with non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Grade two in terms of fatty liver grading
Willingness to participate in the study
no alcohol consumption
age 18-75
Exclusion criteria:
Take drugs with liver toxicity
Recent 3 months of antibiotic use
Hepatitis B and C
cirrhosis
pregnancy and lactation
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
From the patients who volunteered to participate in the study, 80 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
2022-01-19, 1400/10/29
Ethics committee reference number
IR.TBZMED.REC.1400.1095
Health conditions studied
1
Description of health condition studied
Fatty Liver
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Interleukin 6
Timepoint
Before the intervention and after the intervention
Method of measurement
Biochemical tests-ELISA
2
Description
TNF-a level
Timepoint
before and after intervention
Method of measurement
ELISA
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will be included in this group after random allocation. All patients will receive routine treatment and, in addition to routine medications, will take probiotic pills twice daily for three months. Interleukin 6 levels will be measured before the intervention and after the intervention.
Category
Treatment - Other
2
Description
Control group: Patients will be included in this group after random allocation. All patients will receive routine treatment and, in addition to routine medications, will receive two placebo tablets daily for three months. Interleukin 6 levels will be measured before the intervention and after the intervention.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam reza hospital
Full name of responsible person
Tahereh Vaezi
Street address
Emam reza hospital, Golgast st,Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
566614766
Phone
+98 41 3334 4918
Email
farzanehjafarzadeh998@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Golgasht Ave., Emam Reza hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5164886994
Phone
+98 41 3337 2084
Email
Shahabi_p@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
50
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
5981764863
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
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
5981764863
Phone
+98 41 3334 7054
Fax
Email
dinvarim@tbzmed.ac.ir
Person responsible for updating data
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
5981764863
Phone
+98 41 3334 7054
Fax
Email
dinvarim@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available