Effect of Probiotic and Smectite Gel on NAFLD

NCT03614039 | Completed

• 1 other identifier: ENDO-3
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Non-Alcoholic Fatty Liver Disease; Fatty Liver; Liver Diseases; Digestive System Diseases; Type2 Diabetes

Keywords

diosmectite; nutraceuticals; non-alcoholic fatty liver disease; probiotics; Lactobacillus; Bifidobacterium; Propionibacterium

Outcome Measures

Primary Outcomes (2)

• 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

  8 weeks compared to baseline

• liver stiffness (LS)

  liver stiffness (LS) was measured by Shear Wave Elastography (SWE) and expressed in kPa

  8 weeks compared to baseline

Secondary Outcomes (9)

• ALT

  8 weeks compared to baseline

• AST

  8 weeks compared to baseline

• γ-GT

  8 weeks compared to baseline

• Total Cholesterol (TC)

  8 weeks compared to baseline

• Tryglicerides (TG)

  8 weeks compared to baseline

Study Arms (2)

probiotic-smectite

ACTIVE COMPARATOR

Over 8 weeks of interventional period, the patient received 1 sachet (10 grams) of gel per day.

Dietary Supplement: "Symbiter Forte"

placebo

PLACEBO COMPARATOR

Over 8 weeks of interventional period, the patient received 1 sachet (10 grams) of gel per day.

Dietary Supplement: Placebo

Interventions

"Symbiter Forte" DIETARY_SUPPLEMENT

"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)

probiotic-smectite

Placebo DIETARY_SUPPLEMENT

placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult participants (ages 18-75, BMI ≥25 kg/m2) diagnosed with NAFLD according to the recommendations of the American Gastroenterology Association (AGA) and American Association for the Study of Liver Disease (AASLD);
• the diagnosis of fatty liver was based on the results of abdominal ultrasonography. Of 4 known criteria (hepato-renal echo contrast, liver brightness, deep attenuation, and vascular blurring), the participants were required to have hepato-renal contrast and liver brightness to be given a diagnosis of NAFLD.
• type 2 diabetes treated with diet and exercise alone or metformin, SUs and insulin at stable dose at least 4 weeks prior to the commencement of the study;
• AST and ALT ≤3x upper limit of normal.

You may not qualify if:

• alcohol abuse (\>20 g/day (2 standard drinks) in women or \> 30 g/d (3 drinks) in men over a two-year period);
• chronic viral hepatitis (associated with HBV, HCV, HDV infection);
• drug-induced liver disease, Wilson's disease, hereditary deficiency of antitrypsin-1 and idiopathic hemochromatosis;
• history of decompensated liver disease including ascites, encephalopathy or variceal bleeding;
• regular use of a probiotic or prebiotic supplement within 3 months prior to enrollment;
• antibiotic use within 3 months prior to enrollment;
• uncontrolled cardiovascular or respiratory disease, active malignancy, or chronic infections;
• use of agents such as vitamin E, omega-3 fatty acids or medications with evidence for effects on NAFLD (pioglitazone, GLP-1 analogues, dipeptidyl peptidase IV inhibitors, ursodeoxycholic acid);
• presence of active infection, pregnancy or lactation.

Sponsors & Collaborators

• Nazarii Kobyliak: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Petro Bodnar, Prof

  Bogomolets National Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Endocrinology Department, PhD

Study Record Dates

• First Submitted: July 29, 2018
• First Posted: August 3, 2018
• Study Start: September 15, 2015
• Primary Completion: March 15, 2016
• Study Completion: April 20, 2016
• Last Updated: August 7, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share