Probiotic Supplementation and Pancreatic β-Cell Function in Type 2 Diabetes
Condition: Type2 Diabetes; Obesity; Insulin Resistance; Obesity, Abdominal
MeSH terms: Diabetes Mellitus; Obesity; Diabetes Mellitus, Type 2; Insulin Resistance; Obesity, Abdominal
Study type: Interventional

Summary: 
      Probiotics have beneficial effect on obesity related disorders in animal models. Current
      understanding for the beneficial effects of probiotics in type 2 diabetes strictly relies on
      animal and clinical data, which mainly focus on their impact on insulin resistance,
      anthropometric parameters, glycemic control and markers of chronic systemic inflammation.
      From the other hand, there is a lack of evidence-based probiotic efficacy on pancreatic
      β-cell function in terms of type 2 diabetes and related metabolic disorders. In this
      double-blind single center randomized clinical trial, effect of alive multistrain probiotic
      vs. placebo on pancreatic β-cell function in type 2 diabetes patient will be assessed.
    

Detailed description: 
      In this single-center double blind, placebo controlled, parallel group study, type 2 diabetes
      patients from the Kyiv City Clinical Endocrinology Center will be selected. They will be
      randomly assigned to receive multiprobiotic "Symbiter" or placebo for 8-weeks administered as
      a sachet formulation in double-blind treatment. Randomization will be done by the study
      statistician based on a computer-generated list. The groups will be homogeneous according to
      age, sex and diagnostic criteria. The assignment of groups will be 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 multiprobiotic "Symbiter" will be supplied by Scientific and Production Company "O.D.
      Prolisok". It contains of 14 alive probiotic strains of 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 patient received 1 sachet (10 grams) of
      probiotic and placebo per day. All sachets were identical with similar organoleptic
      characteristics (e.g., taste and appearance).

      The pre-randomization period 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 will be instructed in one-on-one sessions with a dietitian to follow a therapeutic
      lifestyle-change diet as classiﬁed by the NCEP. In addition, participants will be instructed
      to continue with stable anti-hyperglycemic treatment and received standardized mild physical
      training for 1 hour per day.

      Patients who underwent study will be instructed to take the trial medication as prescribed.
      Throughout the study, weekly phone follow-up visits will be provided for assessment of
      compliance, adherence to the protocol, as well as the recording of adverse events. The
      effectiveness of therapy will be compared and evaluated separately in the two groups.
    

Intervention name(s): Probiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The multiprobiotic which contains of 14 alive probiotic strains of 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 pa; Over 8 weeks of interventional period, the patient received 1 sachet (10 grams) of gel per day
Other intervention name(s): Symbiter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: probiotics; type 2 diabetes; pancreatic β-cells