Diabetes Mellitus, Type 2NCT06032988
Effect of Probiotic Supplements on Metabolic Control of People With Type 2 Diabetes Mellitus in Greece
A study testing LactoLevure in people with Diabetes Mellitus, Type 2, run by Konstantinos Makrilakis, MD at 1 site in Greece.
Trial summary
The goal of this interventional clinical study is to examine if there will be a change in metabolic indices (glycemic and lipid parameters) among persons with type 2 diabetes (T2D) who will receive a probiotic dietary supplement capsule for 6 months compared to those not receiving such a treatment (they will receive a… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- LactoLevure
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteGreece
- Study dates
- 23 Aug 2023to 2 Sep 2023
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- T2D diagnosis of >6 months' duration
- Age 18-90 years
- A body-mass index (BMI) >18.5 kg/m^2
- HbA1c level >6 percent (%)
- on stable antidiabetic medications (oral or injectable glucagon-like peptide 1 receptor agonists [GLP-1 RAs]) for 8 weeks before the screening
Who cannot join
- Type 1 or other type of diabetes
- Pregnancy or wishing to become pregnant during the study
- End-stage kidney failure on dialysis, presence of other diseases, including cancer or severe hepatic insufficiency (transaminases >3.5x above normal)
- The use of other probiotic products or antibiotics over the previous 6 months
- Participation in other clinical trials
- Insulin administration
- The presence of other medical conditions that in the opinion of the investigators could jeopardize compliance with the protocol (e.g., malabsorption syndrome or an inability to take orally administered medications)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Probiotic Supplements on Metabolic Control of People With Type 2 Diabetes in Greece. A Randomized, Double-blind, Placebo-controlled Study
The goal of this interventional clinical study is to examine if there will be a change in metabolic indices (glycemic and lipid parameters) among persons with type 2 diabetes (T2D) who will receive a probiotic dietary supplement capsule for 6 months compared to those not receiving such a treatment (they will receive a matching placebo capsule that does not contain active ingredients).
The main questions to answer are:
Read more
- Will glycemic indices, i.e., glycated hemoglobin (HbA1c) and fasting blood glucose, be different in people taking the probiotic treatment, compared to those not taking it, after 6 months?
- Will other metabolic indices, mostly blood lipid levels (total cholesterol, triglycerides, HDL- and LDL-cholesterol) and liver function tests, be different in people taking the probiotic treatment compared to those not taking it after 6 months?
- Will adiposity measures (weight, waist circumference) be affected by probiotic treatment in the two groups? Studies in animals and humans, mostly of shorter duration (<12 weeks) so far, have shown a possible trend towards improvement with probiotic treatment in all these parameters, but longer-term studies are scarce, and in Greece, there is none. Since diabetes treatment is complex (usually involving many medications) and expensive, developing cost-effective functional healthcare products for regulating blood glucose more efficiently has been recognized as a beneficial alternative.
Participants will be adult individuals (>18 years old) with T2D, followed at the outpatient Diabetes Center of the Laiko General Hospital, National and Kapodistrian University of Athens Medical School, in Athens, Greece, who will be randomized to receive either a probiotic dietary supplement or a matching placebo capsule, once a day. They will be followed every 3 months (as is customary for diabetic patients). They will be monitored regarding their glycemic control (HbA1c and fasting blood glucose), lipid parameters, liver and renal function, and anthropometric changes (weight, waist circumference, and blood pressure). Furthermore, participants will be asked to give a stool sample at the study's beginning and end (6 months) for gut microbiota analysis. A questionnaire will also be administered at the last visit (6 months) asking about patients' tolerance and satisfaction with the treatment (frequency of constipation, diarrhea, bowel function, bloating, gas production, and abdominal pain).
Read the detailed description
Eligible participants will be randomized using a computer generator (www.randomization.com), which randomizes each subject to a single treatment by using the method of randomly permuted blocks, to receive either a multi-strain probiotic supplement (in the form of a capsule [LactoLevure^R]) or a matching placebo capsule, once a day. The probiotic capsule contains the species: Lactobacillus Acidophilus, Lactobacillus plantarum, Bifidobacterium lactis, Saccharomyces boulardii (in the following quantities of colony-forming units [CFU]: Lactobacillus Acidophilus 1.75x10^9 CFU, Lactobacillus plantarum 0.5x10^9 CFU, Bifidobacterium lactis 1.75x10^9 CFU, Saccharomyces boulardii 1.5x10^9 CFU). The capsules (probiotics brand name LactoLevure^R and placebo) are prepared and donated to the study personnel by an unrestricted research grant from Uni-Pharma Greece, the producer of LactoLevure^R (Uni-Pharma Pharmaceutical Laboratories S.A., Kifisia, Greece), who will have no other interference with the planning, the conduction, or the analysis of the results of the study. The probiotic and placebo capsules will have an identical appearance and packaging. Neither the participants nor the investigators will be aware of the treatment assignments in this double-blinded study. Additionally, participants will be asked not to change their diet and exercise habits and to refrain from consuming yoghurt or other similar dietary supplements during the study. Care will be taken not to change the other pharmaceutical medicines during the study (participants who will have to initiate insulin treatment will be excluded from further follow-up and analysis in the study).
Sample size calculation will be based on previous similar studies considering 80% power at α = 0.05 to detect a difference in metabolic indices. All participants will be given verbal and written information about the study and will sign an informed consent form according to the recommendations of the Declaration of Helsinki.
Participants will be seen every 3 months in the outpatient Diabetes center of the Laiko General Hospital, National and Kapodistrian University of Athens Medical School, in Athens, Greece (as is customary for diabetic patients) and will be monitored regarding their glycemic control (HbA1c and fasting blood glucose), lipid parameters, liver and renal function, and anthropometric variables changes (weight and waist circumference, blood pressure). Furthermore, participants will be asked to give a stool sample at the study's beginning and end (6 months) for gut microbiota analysis. A questionnaire will also be administered at the last visit (6 months) asking about patients' tolerance and satisfaction with the treatment (frequency of constipation, diarrhea, bowel function, bloating, gas production, and abdominal pain).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- LactoLevure
- Keywords
- Diabetes mellitus type 2, Probiotics, Gut microbiota
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactoLevureDietary supplement
Also called Probiotic
Participants will receive LactoLevure^R probiotic dietary supplement or matching placebo once a day.
| Study group | Role | What they receive |
|---|---|---|
| LactoLevure | Active comparator | The probiotic capsule LactoLevure^R will be given once a day Receives: Dietary Supplement: LactoLevure |
| Placebo | Placebo comparator | Placebo capsules will consist of identical to the LactoLevure^R capsules of powdered glucose polymer, and will be given once a day Receives: Dietary Supplement: LactoLevure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of probiotics supplementation on glycemic control (HbA1c)
To measure the difference of the change from baseline in mean HbA1c (percentage points) between the intervention (probiotic) group and placebo, after 6 months
Measured: 6 months
Secondary outcomes (5)
Effects of probiotics supplementation on fasting blood glucose (FBG)
To measure the difference of the change from baseline of mean fasting blood glucose (FBG, mg/dl) between the intervention (probiotic) group and placebo, after 6 months
Measured: 6 months
Effects of probiotics supplementation on lipid parameters (Total cholesterol, Triglycerides, HDL-C, LDL-C)
To measure the difference of the change from baseline of mean blood lipid levels, i.e. total cholesterol (mg/dl), triglycerides (mg/dl), HDL-cholesterol (mg/dl), LDL-cholesterol (mg/dl) between the intervention (probiotic) group and placebo, after 6 months. Any of these blood lipid measurements changes will be reported as lipid effects of the intervention.
Measured: 6 months
Effects of probiotics supplementation on liver function tests (AST, ALT, γGT, Alkaline Phosphatase)
To measure the changes from baseline of mean blood liver function tests, i.e. AST (U/L), ALT (U/L), γGT (U/L) and Alkaline Phosphatase (U/L) between the intervention (probiotic) group and placebo, after 6 months. Any of these liver function test measurements changes will be reported as liver effects of the intervention.
Measured: 6 months
Effects of probiotics supplementation on adiposity measures (BMI, Waist circumference)
To measure the difference of changes from baseline in adiposity characterisitcs (mean body mass index [BMI, kg/m^2] and/or mean waist circumference [cm]) between the intervention (probiotic) and placebo group after 6 months. Either or both of these adiposity measures changes will be reported as adiposity effects of the intervention.
Measured: 6 months
Effects of probiotics supplementation on changes in gut microbiota diversity (alpha- and beta-diversity)
To measure the changes from baseline in stool microbial DNA diversity analyzed through 16S rRNA sequencing between the intervention (probiotic) and placebo group after 6 months. Alpha-diversity will measure the within-group changes in the richness (number) or distribution (evenness) of the microbial sample (in the intervention and the placebo group), whereas beta-diversity will measure the between-groups difference.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start23 Aug 2023
- Primary completion2 Sep 2023
- Study completion2 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Model description
- The present study will be a single-center, randomized, double-blind, placebo-controlled trial of a 6-month duration involving persons with T2D. Participants will receive either a multi-strain probiotic supplement (in the form of a capsule) or a matching placebo capsule once a day.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konstantinos Makrilakis, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Uni-Pharma
- Responsible party
- Sponsor-investigator, Konstantinos Makrilakis, MD, National and Kapodistrian University of Athens
- Investigators
- KONSTANTINOS MAKRILAKIS, MD, PhD, Principal investigator, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032988
- Sponsor's protocol ID
- IRB approval No 306/26.04.2021
- Status last verified
- May 2025
- First submitted
- 27 Aug 2023
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participants' data will be deposited anonymized in "Pergamos", the central Institutional Repository of the National and Kapodistrian University of Athens
Publications
Bock PM, Telo GH, Ramalho R, Sbaraini M, Leivas G, Martins AF, Schaan BD. The effect of probiotics, prebiotics or synbiotics on metabolic outcomes in individuals with diabetes: a systematic review and meta-analysis. Diabetologia. 2021 Jan;64(1):26-41. doi: 10.1007/s00125-020-05295-1. Epub 2020 Oct 13.
PubMed 33047170Rittiphairoj T, Pongpirul K, Janchot K, Mueller NT, Li T. Probiotics Contribute to Glycemic Control in Patients with Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis. Adv Nutr. 2021 Jun 1;12(3):722-734. doi: 10.1093/advances/nmaa133.
PubMed 33126241Vallianou NG, Stratigou T, Tsagarakis S. Microbiome and diabetes: Where are we now? Diabetes Res Clin Pract. 2018 Dec;146:111-118. doi: 10.1016/j.diabres.2018.10.008. Epub 2018 Oct 18.
PubMed 30342053
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotic Supplements on Metabolic Control of People With Type 2 Diabetes in Greece. A Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT06032988
- Acronym / sponsor ID
- IRB approval No 306/26.04.2021
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes mellitus type 2, Probiotics, Gut microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Konstantinos Makrilakis, MDUniversity, hospital or other
- Collaborators
- Uni-Pharma
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 2 Sep 2023 (actual)
- Study completion
- 2 Sep 2023 (actual)
- First posted
- 13 Sep 2023 (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.
The goal of this interventional clinical study is to examine if there will be a change in metabolic indices (glycemic and lipid parameters) among persons with type 2 diabetes (T2D) who will receive a probiotic dietary supplement capsule for 6 months compared to those not receiving such a treatment (they will receive a matching placebo capsule that does not contain active ingredients).
The main questions to answer are:
- Will glycemic indices, i.e., glycated hemoglobin (HbA1c) and fasting blood glucose, be different in people taking the probiotic treatment, compared to those not taking it, after 6 months?
- Will other metabolic indices, mostly blood lipid levels (total cholesterol, triglycerides, HDL- and LDL-cholesterol) and liver function tests, be different in people taking the probiotic treatment compared to those not taking it after 6 months?
- Will adiposity measures (weight, waist circumference) be affected by probiotic treatment in the two groups? Studies in animals and humans, mostly of shorter duration (<12 weeks) so far, have shown a possible trend towards improvement with probiotic treatment in all these parameters, but longer-term studies are scarce, and in Greece, there is none. Since diabetes treatment is complex (usually involving many medications) and expensive, developing cost-effective functional healthcare products for regulating blood glucose more efficiently has been recognized as a beneficial alternative.
Participants will be adult individuals (>18 years old) with T2D, followed at the outpatient Diabetes Center of the Laiko General Hospital, National and Kapodistrian University of Athens Medical School, in Athens, Greece, who will be randomized to receive either a probiotic dietary supplement or a matching placebo capsule, once a day. They will be followed every 3 months (as is customary for diabetic patients). They will be monitored regarding their glycemic control (HbA1c and fasting blood glucose), lipid parameters, liver and renal function, and anthropometric changes (weight, waist circumference, and blood pressure). Furthermore, participants will be asked to give a stool sample at the study's beginning and end (6 months) for gut microbiota analysis. A questionnaire will also be administered at the last visit (6 months) asking about patients' tolerance and satisfaction with the treatment (frequency of constipation, diarrhea, bowel function, bloating, gas production, and abdominal pain).
Detailed description
Eligible participants will be randomized using a computer generator (www.randomization.com), which randomizes each subject to a single treatment by using the method of randomly permuted blocks, to receive either a multi-strain probiotic supplement (in the form of a capsule [LactoLevure^R]) or a matching placebo capsule, once a day. The probiotic capsule contains the species: Lactobacillus Acidophilus, Lactobacillus plantarum, Bifidobacterium lactis, Saccharomyces boulardii (in the following quantities of colony-forming units [CFU]: Lactobacillus Acidophilus 1.75x10^9 CFU, Lactobacillus plantarum 0.5x10^9 CFU, Bifidobacterium lactis 1.75x10^9 CFU, Saccharomyces boulardii 1.5x10^9 CFU). The capsules (probiotics brand name LactoLevure^R and placebo) are prepared and donated to the study personnel by an unrestricted research grant from Uni-Pharma Greece, the producer of LactoLevure^R (Uni-Pharma Pharmaceutical Laboratories S.A., Kifisia, Greece), who will have no other interference with the planning, the conduction, or the analysis of the results of the study. The probiotic and placebo capsules will have an identical appearance and packaging. Neither the participants nor the investigators will be aware of the treatment assignments in this double-blinded study. Additionally, participants will be asked not to change their diet and exercise habits and to refrain from consuming yoghurt or other similar dietary supplements during the study. Care will be taken not to change the other pharmaceutical medicines during the study (participants who will have to initiate insulin treatment will be excluded from further follow-up and analysis in the study).
Sample size calculation will be based on previous similar studies considering 80% power at α = 0.05 to detect a difference in metabolic indices. All participants will be given verbal and written information about the study and will sign an informed consent form according to the recommendations of the Declaration of Helsinki.
Participants will be seen every 3 months in the outpatient Diabetes center of the Laiko General Hospital, National and Kapodistrian University of Athens Medical School, in Athens, Greece (as is customary for diabetic patients) and will be monitored regarding their glycemic control (HbA1c and fasting blood glucose), lipid parameters, liver and renal function, and anthropometric variables changes (weight and waist circumference, blood pressure). Furthermore, participants will be asked to give a stool sample at the study's beginning and end (6 months) for gut microbiota analysis. A questionnaire will also be administered at the last visit (6 months) asking about patients' tolerance and satisfaction with the treatment (frequency of constipation, diarrhea, bowel function, bloating, gas production, and abdominal pain).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The present study will be a single-center, randomized, double-blind, placebo-controlled trial of a 6-month duration involving persons with T2D. Participants will receive either a multi-strain probiotic supplement (in the form of a capsule) or a matching placebo capsule once a day.
| Arm | Type | Receives |
|---|---|---|
| LactoLevure | Active comparator | Dietary Supplement: LactoLevureThe probiotic capsule LactoLevure^R will be given once a day |
| Placebo | Placebo comparator | Dietary Supplement: LactoLevurePlacebo capsules will consist of identical to the LactoLevure^R capsules of powdered glucose polymer, and will be given once a day |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- T2D diagnosis of >6 months' duration
- Age 18-90 years
- A body-mass index (BMI) >18.5 kg/m^2
- HbA1c level >6 percent (%)
- on stable antidiabetic medications (oral or injectable glucagon-like peptide 1 receptor agonists [GLP-1 RAs]) for 8 weeks before the screening
Key exclusion criteria (7 listed)
- Type 1 or other type of diabetes
- Pregnancy or wishing to become pregnant during the study
- End-stage kidney failure on dialysis, presence of other diseases, including cancer or severe hepatic insufficiency (transaminases >3.5x above normal)
- The use of other probiotic products or antibiotics over the previous 6 months
- Participation in other clinical trials
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 |
|---|---|---|
| LactoLevureAlso: ProbioticParticipants will receive LactoLevure^R probiotic dietary supplement or matching placebo once a day. | Dietary supplement | LactoLevure, Placebo |
Primary outcome
Effects of probiotics supplementation on glycemic control (HbA1c)
Time frame: 6 months
To measure the difference of the change from baseline in mean HbA1c (percentage points) between the intervention (probiotic) group and placebo, after 6 months
5 secondary outcomes
Effects of probiotics supplementation on fasting blood glucose (FBG)
Time frame: 6 months
Effects of probiotics supplementation on lipid parameters (Total cholesterol, Triglycerides, HDL-C, LDL-C)
Time frame: 6 months
Effects of probiotics supplementation on liver function tests (AST, ALT, γGT, Alkaline Phosphatase)
Time frame: 6 months
Effects of probiotics supplementation on adiposity measures (BMI, Waist circumference)
Time frame: 6 months
Effects of probiotics supplementation on changes in gut microbiota diversity (alpha- and beta-diversity)
Time frame: 6 months
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 30 May 2025.
- Background: PubMed 33047170Bock PM, Telo GH, Ramalho R, Sbaraini M, Leivas G, Martins AF, Schaan BD. The effect of probiotics, prebiotics or synbiotics on metabolic outcomes in individuals with diabetes: a systematic review and meta-analysis. Diabetologia. 2021 Jan;64(1):26-41. doi: 10.1007/s00125-020-05295-1. Epub 2020 Oct 13.
- Background: PubMed 33126241Rittiphairoj T, Pongpirul K, Janchot K, Mueller NT, Li T. Probiotics Contribute to Glycemic Control in Patients with Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis. Adv Nutr. 2021 Jun 1;12(3):722-734. doi: 10.1093/advances/nmaa133.
- Background: PubMed 30342053Vallianou NG, Stratigou T, Tsagarakis S. Microbiome and diabetes: Where are we now? Diabetes Res Clin Pract. 2018 Dec;146:111-118. doi: 10.1016/j.diabres.2018.10.008. Epub 2018 Oct 18.
- Individual participant dataSharing planned: Yes. Individual participants' data will be deposited anonymized in "Pergamos", the central Institutional Repository of the National and Kapodistrian University of Athens
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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.
KONSTANTINOS MAKRILAKIS, MD, PhD principal investigator
National and Kapodistrian University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LactoLevure in people with Diabetes Mellitus, Type 2, run by Konstantinos Makrilakis, MD at 1 site in Greece.
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 5 inclusion and 7 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 30 May 2025. 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 Greece. 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?
Effects of probiotics supplementation on glycemic control (HbA1c) (time frame: 6 months). 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 NCT06032988, which also lists 3 linked publications.
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 30 May 2025.