ObesityNCT04293731
Smectite Gel and Probiotic for Obesity and Insulin Resistance
A study testing Symbiter-Smectite in people with Obesity and Insulin Resistance, run by Bogomolets National Medical University at 1 site in Ukraine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Insulin Resistance, Insulin Sensitivity
- What is being tested?
- Symbiter-Smectite
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUkraine
- Study dates
- 1 Nov 2018to 28 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult participants (ages 18-75, BMI ≥25 kg/m2)
- presence of type 2 diabetes diagnosed according to criteria of the American Diabetes Association (fasting plasma glucose (FPG)≥7.0mmol/l, random plasma glucose ≥11.1mmol/l, HbA1c ≥6.5%, or glucose higher than 11.1mmol/l 2 hours after a 75-g oral glucose load);
- type 2 diabetes duration 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-2IR≥2.0;
- HbA1c between 6.5 and 11.0 %;
- written informed consent.
Who cannot join
- 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;
- allergy on probiotics or their components;
- presence of gastrointestinal diseases such as food allergy, celiac disease, non-specific ulcerative colitis;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Co-administration of Smectite Gel With Live Probiotic Strains on Obesity Parameters and Insulin Resistance
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.
Read the 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.
- Conditions
- Obesity, Insulin Resistance, Insulin Sensitivity, Type2 Diabetes Mellitus, Visceral Obesity
- Being tested
- Symbiter-Smectite, Placebo
- Keywords
- Smectite, Probiotic, Lactobacillus, Bifidobacterium, Propionibacterium, Acetobacter, Obesity, Type2 Diabetes, Insulin Resistance
- Medical subject headings
- Obesity, Insulin Resistance, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symbiter-SmectiteDietary supplement
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)
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Symbiter-Smectite | Active comparator | Over 8 weeks of interventional period, the patient received 1 sachet (10 grams) per day Receives: Dietary Supplement: Symbiter-Smectite |
| Placebo | Placebo comparator | Over 8 weeks of interventional period, the patient received 1 sachet (10 grams) per day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HOMA-2IR
This model can be calculated using the software supplied by the Oxford Centre for Diabetes Endocrinology and Metabolism available at http://www.dtu.ox.ac.uk/homacalculator/index.php
Measured: 8 weeks compared to baseline
insulin sensitivity (%S)
This model can be calculated using the software supplied by the Oxford Centre for Diabetes Endocrinology and Metabolism available at http://www.dtu.ox.ac.uk/homacalculator/index.php
Measured: 8 weeks compared to baseline
Secondary outcomes (8)
HbA1c
HbA1c in %
Measured: 8 weeks compared to baseline
fasting plasma glucose (FPG)
FPG in mmol/L
Measured: 8 weeks compared to baseline
β-cell function (%B)
(%B)
Measured: 8 weeks compared to baseline
C-peptide
C-peptide, ng/ml
Measured: 8 weeks compared to baseline
weight
weight in kg
Measured: 8 weeks compared to baseline
waist circumferences (WC)
WC in cm
Measured: 8 weeks compared to baseline
body mass index (BMI)
weight in kg and height in meters will be combined to report BMI in kg/m^2
Measured: 8 weeks compared to baseline
cytokines levels
TNF-α, IL-1β, IL-6, IL-8, INF-γ
Measured: 8 weeks compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start1 Nov 2018
- Primary completion25 May 2019
- Study completion28 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bogomolets National Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Taras Shevchenko National University of Kyiv
- Responsible party
- Principal investigator, Nazarii Kobyliak, Bogomolets National Medical University
- Investigators
- Nazarii Kobyliak, PhD, Principal investigator, Bogomolets National Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293731
- Sponsor's protocol ID
- ENDO-6
- Status last verified
- Jun 2023
- First submitted
- 1 Mar 2020
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kobyliak N, Abenavoli L, Falalyeyeva T, Kovalchuk O, Kyriienko D, Komisarenko I. Metabolic Benefits of Probiotic Combination with Absorbent Smectite in type 2 Diabetes Patients a Randomised Controlled Trial. Rev Recent Clin Trials. 2021;16(1):109-119. doi: 10.2174/1574887115666200709141131.
PubMed 32646362
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-administration of Smectite Gel With Live Probiotic Strains on Obesity Parameters and Insulin Resistance
- ClinicalTrials.gov ID
- NCT04293731
- Acronym / sponsor ID
- ENDO-6
- Conditions
- Obesity, Insulin Resistance, Insulin Sensitivity, Type2 Diabetes Mellitus, Visceral Obesity
- Keywords
- Smectite, Probiotic, Lactobacillus, Bifidobacterium, Propionibacterium, Acetobacter, Obesity, Type2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Bogomolets National Medical UniversityUniversity, hospital or other
- Collaborators
- Taras Shevchenko National University of Kyiv
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 25 May 2019 (actual)
- Study completion
- 28 May 2019 (actual)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symbiter-Smectite | Active comparator | Dietary Supplement: Symbiter-SmectiteOver 8 weeks of interventional period, the patient received 1 sachet (10 grams) per day |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOver 8 weeks of interventional period, the patient received 1 sachet (10 grams) per day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- adult participants (ages 18-75, BMI ≥25 kg/m2)
- presence of type 2 diabetes diagnosed according to criteria of the American Diabetes Association (fasting plasma glucose (FPG)≥7.0mmol/l, random plasma glucose ≥11.1mmol/l, HbA1c ≥6.5%, or glucose higher than 11.1mmol/l 2 hours after a 75-g oral glucose load);
- type 2 diabetes duration 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-2IR≥2.0;
Key exclusion criteria (9 listed)
- 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;
- allergy on probiotics or their components;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symbiter-SmectiteSymbiter-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 | Symbiter-Smectite |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
HOMA-2IR
Time frame: 8 weeks compared to baseline
This model can be calculated using the software supplied by the Oxford Centre for Diabetes Endocrinology and Metabolism available at http://www.dtu.ox.ac.uk/homacalculator/index.php
insulin sensitivity (%S)
Time frame: 8 weeks compared to baseline
This model can be calculated using the software supplied by the Oxford Centre for Diabetes Endocrinology and Metabolism available at http://www.dtu.ox.ac.uk/homacalculator/index.php
8 secondary outcomes
HbA1c
Time frame: 8 weeks compared to baseline
fasting plasma glucose (FPG)
Time frame: 8 weeks compared to baseline
β-cell function (%B)
Time frame: 8 weeks compared to baseline
C-peptide
Time frame: 8 weeks compared to baseline
weight
Time frame: 8 weeks compared to baseline
waist circumferences (WC)
Time frame: 8 weeks compared to baseline
body mass index (BMI)
Time frame: 8 weeks compared to baseline
cytokines levels
Time frame: 8 weeks compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Results publication: PubMed 32646362Kobyliak N, Abenavoli L, Falalyeyeva T, Kovalchuk O, Kyriienko D, Komisarenko I. Metabolic Benefits of Probiotic Combination with Absorbent Smectite in type 2 Diabetes Patients a Randomised Controlled Trial. Rev Recent Clin Trials. 2021;16(1):109-119. doi: 10.2174/1574887115666200709141131.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazarii Kobyliak, PhD principal investigator
Bogomolets National Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symbiter-Smectite in people with Obesity and Insulin Resistance, run by Bogomolets National Medical University at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HOMA-2IR (time frame: 8 weeks compared to baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04293731, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.