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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03434860
Other study ID # ENDO-4
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2016
Est. completion date January 25, 2017

Study information

Verified date December 2019
Source Bogomolets National Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Probiotics have beneficial effect on obesity related disorders in animal models. Despite a large number of animal data, randomized placebo-controlled trials (RCT) concluded that probiotics have a moderate effect on glycemic control-related parameters. However, effect of probiotics on insulin resistance are inconsistent. In this double-blind single center RCT, effect of alive multistrain probiotic vs. placebo on insulin resistance in type 2 diabetes patient will be assessed.


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.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date January 25, 2017
Est. primary completion date November 20, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- adult participants (ages 18-75, BMI =25 kg/m2) diagnosed with T2D according WHO (1999) for at least 6 months prior to the study;

- patient who treated with diet and exercise alone or metformin, SUs and insulin on a stabilized dose for at least 3 months before the study;

- presence of insulin resistance established as HOMA-IR=2.0;

- HbA1c between 6.5 and 11.0 %;

- written informed consent.

Exclusion Criteria:

- presence of type 1 diabetes;

- treatment with other than mention in inclusion criteria antidiabetic drugs (pioglitazone, GLP-1 analogues, DPP IV inhibitors etc);

- 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, decompensated liver disease including ascites, encephalopathy or variceal bleeding, active malignancy, or chronic infections;

- participation in other clinical trials;

- presence of pregnancy or lactation.

Study Design


Intervention

Dietary Supplement:
probiotic
The multiprobiotic "Symbiter" 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 patient received 1 sachet (10 grams) of probiotic per day.
placebo
Over 8 weeks of interventional period, the patient received 1 sachet (10 grams) of gel per day

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bogomolets National Medical University

References & Publications (1)

Kobyliak N, Falalyeyeva T, Mykhalchyshyn G, Kyriienko D, Komissarenko I. Effect of alive probiotic on insulin resistance in type 2 diabetes patients: Randomized clinical trial. Diabetes Metab Syndr. 2018 Sep;12(5):617-624. doi: 10.1016/j.dsx.2018.04.015. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary HOMA-IR HOMA-IR was calculated according to the formula: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5 8 weeks compared to baseline
Secondary HbA1c HbA1c in % 8 weeks compared to baseline
Secondary fasting plasma insulins (FPI) FPI in microU/L 8 weeks compared to baseline
Secondary fasting plasma glucose (FPG) FPG in mmol/L 8 weeks compared to baseline
Secondary weight weight in kg 8 weeks compared to baseline
Secondary waist circumferences (WC) WC in cm 8 weeks compared to baseline
Secondary body mass index (BMI) weight and height will be combined to report BMI in kg/m^2 8 weeks compared to baseline
Secondary cytokines levels TNF-a, IL-1ß, IL-6, IL-8, INF-? 8 weeks compared to baseline
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