Protocol summary
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Study aim
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Determining the effect of probiotics on body mass index, fasting serum sugar, lipid factors (triglyceride level, total cholesterol, LDL, HDL), liver enzymes (AST and ALT) and ultrasound evidence of liver in children and adolescents 10 to 18 years with disease Non-alcoholic fatty liver
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Design
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Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 60 patients, randomization list through www. sealedenvelope.com/simple-randomiser/v1/lists
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Settings and conduct
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Children and adolescents with non-alcoholic fatty liver disease referred to the clinic of Shahid Beheshti Hospital in Kashan will be randomly divided to receive Familact supplement or placebo for 8 weeks.
In order to blind patients, the same drug (in terms of shape, size and color) will be prepared with the main drug.
In order to blind the clinical caregiver (physicians or nutritionist), the drugs used for patients will be provided in coded form.
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Participants/Inclusion and exclusion criteria
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Children and adolescents 10 to 18 years with non-alcoholic fatty liver disease
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Intervention groups
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Intervention group: Receiving Familact supplement for 8 weeks (Familact 500 mg prepared from Biology fermentation Company, once a day after meals)
Control group: receiving placebo for 8 weeks once a day after meals
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Main outcome variables
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body mass index, fasting serum sugar, lipid factors (triglyceride level, total cholesterol, LDL, HDL), liver enzymes (AST and ALT) and ultrasound evidence of liver
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220314054279N1
Registration date:
2022-03-17, 1400/12/26
Registration timing:
retrospective
Last update:
2022-07-19, 1401/04/28
Update count:
1
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Registration date
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2022-03-17, 1400/12/26
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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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2021-01-20, 1399/11/01
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Expected recruitment end date
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2021-10-22, 1400/07/30
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Actual recruitment start date
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2021-01-20, 1399/11/01
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Actual recruitment end date
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2021-10-22, 1400/07/30
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Trial completion date
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2021-12-22, 1400/10/01
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Scientific title
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The effect of probiotics on changes in liver enzymes, lipid factors and ultrasound evidence in children and adolescents aged 10 to 18 years with non-alcoholic fatty liver
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Public title
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The effect of probiotics on changes in liver enzymes, lipid factors and ultrasound evidence in children and adolescents aged 10 to 18 years with non-alcoholic 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:
Children and adolescents 10 to 18 years of age with non-alcoholic fatty liver disease confirmed by ultrasound and ALT more than 1.5 to 5 times normal
Exclusion criteria:
Patients with alcoholic steatohepatitis
Patients with systemic diseases (such as diabetes), inflammatory diseases, autoimmune diseases of the liver
Positive serology of viral hepatitis
Positive AMA ANA
Positive Ceruloplasmin
Children with hypothyroidism
Taking nutritional supplements
Other secondary causes of fatty liver
Patients with any medication that affects the liver
Liver enzyme levels are more than 6 times normal
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Age
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From 10 years old to 18 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
- Care provider
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Sample size
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Target sample size:
60
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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First, the intervention group was coded with the letter A and the control group with the letter B, and then using the website www. sealedenvelope.com/simple-randomiser/v1/lists randomization list was prepared by selecting a sample size of 60 (two groups of 30) and permuted block randomization method (block size=4) (15 blocks of 4). Then, through the obtained randomization list, the subjects included in the study will be assigned to one of the two groups A or B. For example, suppose that in the first four blocks, the permutation method is ABBA, so the first and fourth samples will be assigned to group A and the second and third samples to group B and the same will continue until the last sample (60th person).
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In order to blind patients, the same drug (in terms of shape, size and color) will be prepared with the main drug.
In order to blind the clinical caregiver (physicians or nutritionist), the drugs used for patients will be provided in coded form.
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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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2020-11-11, 1399/08/21
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Ethics committee reference number
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IR.KAUMS.MEDNT.REC.1399.144
Health conditions studied
1
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Description of health condition studied
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Non-alcoholic fatty liver disease
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ICD-10 code
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DB92
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ICD-10 code description
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Non-alcoholic fatty liver disease
Primary outcomes
1
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Description
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Liver enzymes (ALT,AST)
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Timepoint
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At the beginning of the study, 8 weeks after taking the drug
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Method of measurement
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blood test
2
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Description
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Lipid factors (cholesterol, LDL, HDL)
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Timepoint
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At the beginning of the study, 8 weeks after taking the drug
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Method of measurement
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blood test
3
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Description
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Fatty liver grade
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Timepoint
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At the beginning of the study, 8 weeks after taking the drug
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Method of measurement
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Sonography
Secondary outcomes
1
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Description
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Body mass index
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Timepoint
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At the beginning of the study, 8 weeks after taking the drug
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Method of measurement
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Meters to measure height and scales to measure weight
2
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Description
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Fasting blood sugar
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Timepoint
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At the beginning of the study, 8 weeks after taking the drug
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Method of measurement
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Blood test
Intervention groups
1
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Description
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Intervention group: Receive 500 mg Familact Capsules (Probiotic + Prebiotic) prepared from Zist Takhmir Company, once a day after meals for 8 weeks
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Category
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Treatment - Drugs
2
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Description
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Control group: Receive placebo capsule (in the form of Familact drug without existing bacteria) prepared from Zist Takhmir company, once a day after meals for 8 weeks
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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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Kashan 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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Undecided - It is not yet known if there will be 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