Smectite Gel and Probiotic for Obesity and Insulin Resistance
Condition: Obesity; Insulin Resistance; Insulin Sensitivity; Type2 Diabetes Mellitus; Visceral Obesity
MeSH terms: Obesity; Diabetes Mellitus, Type 2; Insulin Resistance; Obesity, Abdominal
Study type: Interventional

Summary: 
      Probiotics are defined as live microorganisms that, when administered in adequate amounts,
      confer a health benefit on the host. Smectite is a natural silicate clay belonging to the
      dioctahedral smectite class formed from aluminomagnesium silicate. It is not absorbed from
      the gastrointestinal tract, but binds to intestinal mucous, forms multilayer structure with
      high plastic viscosity and powerful coating properties hence preserving integrity of the
      mucus, and has the ability to absorb directly bacterial toxins, bacteria, viruses and bile
      salts. The current study aim was to conduct placebo-controlled randomize clinical trial for
      the efficiency of a combination of multiprobiotics with smectite (Symbiter-Forte formulation)
      as an adjunction to the standard anti-diabetic therapy on IR, glycemic control parameters,
      β-cells functional activity, anthropometric parameters and markers of a chronic systemic
      inflammatory response in type 2 diabetes patients.
    

Detailed description: 
      In this single-center double-blind, placebo controlled, parallel group study, 55 type 2
      diabetes patients from the Kyiv City Clinical Endocrinology Center were selected. They were
      randomly assigned to receive "Symbiter Smectite" 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 Smectite" was supplied by Scientific and Production Company "O.D. Prolisok". It
      contains a biomass of alive probiotic microorganism symbiosis, colony forming units - CFU/g:
      Lactobacillus - 1.0х109, Bifidobacterium - 1.0х109, Lactococcus - 1.0х108, Propionibacterium
      - 1.0х108 and Acetobacter - 1.0х105; and smectite gel (250 mg). Over 8 weeks of
      interventional period, the patient 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 start, after inform consent
      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-Smectite; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Symbiter-Smectite contains biomass of alive probiotic microorganism symbiosis, colony forming units - CFU/g: Lactobacillus - 1.0х109, Bifidobacterium - 1.0х109, Lactococcus - 1.0х108, Propionibacterium - 1.0х108 and Acetobacter - 1.0х105; and smectite gel (250 mg); Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Smectite; Probiotic; Lactobacillus; Bifidobacterium; Propionibacterium; Acetobacter; Obesity; Type2 Diabetes; Insulin Resistance