Effect of Probiotic and Smectite Gel on NAFLD
Condition: Non-Alcoholic Fatty Liver Disease; Fatty Liver; Liver Diseases; Digestive System Diseases; Type2 Diabetes
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Digestive System Diseases; Gastrointestinal Diseases
Study type: Interventional

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
    

Detailed description: 
      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.
    

Intervention name(s): "Symbiter Forte"; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): "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)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diosmectite; nutraceuticals; non-alcoholic fatty liver disease; probiotics; Lactobacillus; Bifidobacterium; Propionibacterium