An interventional study of "Symbiter Forte" and Placebo in Non-Alcoholic Fatty Liver Disease, Fatty Liver and Liver Diseases, sponsored by Nazarii Kobyliak. Completed. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-08-07.
Sponsored by Nazarii Kobyliak · Not applicable, Interventional, and Treatment
Smectite is a natural silicate clay belonging to the dioctahedral smectite class and has the ability directly to absorb bacterial toxins, bacteria, viruses and bile salts. Diosmectite also has a protective effect against intestinal inflammation hence suppressing production of cytokines such as IL-8 and TNFα. Investigators suggested that all these pharmacological properties may be beneficial for the treatment of NAFLD. Based on preclinical data, in rats with MSG induced obesity supplementation of alive probiotics with smectite gel (Symbiter-Forte) due to his absorbent activity lead to significant reduction of chronic systemic inflammatory markers, lower total NAS (NAFLD activity score) score, with more pronounced reduction of lobular inflammation as compared to administration of probiotic alone. In respect to preclinical data, in this double-blind single center randomized clinical trial (RCT) the efficacy of alive probiotics supplementation with smectite gel (Symbiter-Forte) vs. placebo in type-2 diabetes patient with NAFLD detected on ultrasonography will be studied
In this single-center double-blind, placebo controlled, parallel group study, 50 T2D patients from the Kyiv City Clinical Endocrinology Center - Ukraine, were selected. They were randomly assigned to receive "Symbiter Forte" or placebo for 8 weeks, administered as a sachet formulation in double-blind treatment. Randomization was done by the study statistician based on a computer-generated list. The groups were homogeneous according to age, sex and diagnostic criteria. The assignment of groups was blind to participants, research staff and outcome assessors moreover, to maintain blind parallel study the statistician was not aware of the allocation of participants to intervention.
The "Symbiter Forte" was supplied by Scientific and Production Company "O.D. Prolisok". It contains combination of smectite gel (250 mg), supplemented with biomass of 14 alive probiotic strains: Lactobacillus + Lactococcus (6×1010 CFU/g), Bifidobacterium (1×1010/g), Propionibacterium (3×1010/g), Acetobacter (1×106/g) genera. Over 8 weeks of interventional period, the patients received 1 sachet (10 grams) of probiotic-smectite and placebo per day. All sachets were identical with similar organoleptic characteristics (e.g., taste and appearance).
The pre-randomization period was designed to minimize the effects of dietary changes on metabolic markers. For this purpose, 2 weeks before the study started, after the informed consent was signed, patients were instructed in one-on-one sessions with a dietitian to follow a therapeutic lifestyle-change diet as classified by the NCEP. In addition, participants were instructed to continue with stable anti-hyperglycemic treatment and received standardized mild physical training for 1 hour per day.
Patients who underwent the study were instructed to take the trial medication as prescribed. Throughout the study, weekly phone follow-up visits were provided for assessment of compliance, adherence to the protocol, as well as the recording of adverse events. The effectiveness of therapy was compared and evaluated separately in the two groups.
1,617 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 324 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 1,176 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →Nazarii Kobyliak is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Over 8 weeks of interventional period, the patient received 1 sachet (10 grams) of gel per day.
Dietary Supplement: "Symbiter Forte"
Over 8 weeks of interventional period, the patient received 1 sachet (10 grams) of gel per day.
Dietary Supplement: Placebo
"Symbiter Forte" which contains combination of smectite gel (250 mg), and biomass of 14 alive probiotic strains: Lactobacillus + Lactococcus (6×1010 CFU/g), Bifidobacterium (1×1010/g), Propionibacterium (3×1010/g), Acetobacter (1×106/g)
fatty liver index (FLI)
FLI = \[e 0.953\*loge (triglycerides) + 0.139\*BMI + 0.718\*loge (ggt) + 0.053\*waist circumference - 15.745) / (1 + e 0.953\*loge (triglycerides) + 0.139\*BMI + 0.718\*loge (ggt) + 0.053\*waist circumference - 15.745)\] × 100
Time frame: 8 weeks compared to baseline
liver stiffness (LS)
liver stiffness (LS) was measured by Shear Wave Elastography (SWE) and expressed in kPa
Time frame: 8 weeks compared to baseline
ALT
ALT in IU/L
Time frame: 8 weeks compared to baseline
AST
AST in IU/L
Time frame: 8 weeks compared to baseline
γ-GT
γ-GT in IU/L
Time frame: 8 weeks compared to baseline
Total Cholesterol (TC)
TC in mmol/l
Time frame: 8 weeks compared to baseline
Tryglicerides (TG)
TG in mmol/l
Time frame: 8 weeks compared to baseline
LDL-Cholesterol (LDL-C)
LDL-C in mmol/l
Time frame: 8 weeks compared to baseline
VLDL-Cholesterol (VLDL-C)
VLDL-C in mmol/l
Time frame: 8 weeks compared to baseline
HDL-Cholesterol (HDL-C)
HDL-C in mmol/l
Time frame: 8 weeks compared to baseline
cytokines levels
TNF-α, IL-1β, IL-6, IL-8, INF-γ in pg/ml
Time frame: 8 weeks compared to baseline
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2015 to primary completion in Mar 2016, 6 months.
Of 357 non-industry interventional studies with no phase under Non-alcoholic Fatty Liver Disease, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 51. This study's 6 months is below that.
Counting every sponsor, half of 385 studies reached it within 26 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Non-alcoholic Fatty Liver Disease →
Nazarii Kobyliak