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Smectite Gel and Probiotic for Obesity and Insulin Resistance

NCT04293731 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2023-06-15

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Symbiter-Smectite

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)

DIETARY_SUPPLEMENT

Placebo

Placebo

Sponsors & Collaborators

  • Taras Shevchenko National University of Kyiv

    collaborator OTHER

  • Bogomolets National Medical University

    lead OTHER

Principal Investigators

  • Nazarii Kobyliak, PhD · Bogomolets National Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2019-05-25
Completion
2019-05-28

Countries

  • Ukraine

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04293731 on ClinicalTrials.gov