Diabetes Mellitus (Type 2)NCT07330388
Probiotic Effects in Type 2 Diabetes
A study testing Probiotic group in people with Diabetes Mellitus (Type 2) and Inflammation, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Adult-onset diabetes is a disease characterized by high blood glucose levels and is one of the leading causes of cardiovascular disease, blindness, end-stage renal failure, and hospitalization. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Diabetes Mellitus (Type 2), Inflammation, Probiotics
- What is being tested?
- Probiotic group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2020to 1 Jun 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 35-65 years
- Previously diagnosed with T2DM
- Volunteering to participate in this study.
Who cannot join
- Use of any systemic antibiotics, multivitamins, minerals, herbal medicines, prebiotic, probiotic and postbiotic supplements in the last 3-6 months
- Having a diagnosis of any inflammatory bowel disease, severe renal dysfunction or hepatic dysfunction, immunodeficiency diseases, acute infection, rheumatoid arthritis, cancer history
- history of alcohol abuse or drug dependence,
- pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Faculty of Medicine
Izmir, 35100
About this study
Official title: The Effects of Probiotics on Metabolic Biomarkers, Inflammation, and the Antioxidant System in Patients With Type 2 Diabetes Mellitus
Adult-onset diabetes is a disease characterized by high blood glucose levels and is one of the leading causes of cardiovascular disease, blindness, end-stage renal failure, and hospitalization. Recent studies support the idea that bacteria found in the gut may play an important role in the development and progression of diabetes. Changes in the gut bacterial environment can affect blood glucose and blood lipids. A increasing number of recent studies have shown that probiotics can alter the gut bacterial environment and reduce blood glucose and blood lipids. The aim of this study is to investigate the effects of probiotics, administered in addition to your current medications, on blood glucose and blood lipids.
Read the detailed description
Participants aged 35-65 years diagnosed with T2DM were allocated sequentially according to order of presentation to either probiotic group (n=39) or control group (n=38). The intervention group received a multi-strain probiotic supplement containing Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium lactis and Lactobacillus paracasei, twice daily for 12 weeks, while the control group continued standard care. This study evaluated anthropometric measurements, eating attitudes, dietary frequency, quality of life, and physical activity. Biochemical analyses included glycemic control, lipid profiles, inflammation markers (high-sensitivity C-Reactive Protein, Ceruloplasmin), and oxidative stress markers (Malondialdehyde, Glutathione).
- Conditions
- Diabetes Mellitus (Type 2), Inflammation, Probiotics, Antioxidant Effect, Glucose Metabolism, Lipid Metabolism
- Being tested
- Probiotic group
- Medical subject headings
- Diabetes Mellitus, Type 2, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic groupDietary supplement
Patients in the intervention group were given a probiotic supplement containing Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium lactis and Lactobacillus paracasei, each containing 1.25 billion live microorganisms, without vitamins and minerals, twice a day in addition to their current treatment for 12 weeks (Probiotic group). Patients in the control group were not given any additional treatment and were allowed to continue their routine antidiabetic treatment for 12 weeks (Control group).
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | Patients in the intervention group were given a probiotic supplement containing Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium lactis and Lactobacillus paracasei, each containing 1.25 billion live microorganisms, without vitamins and minerals, twice a day in addition to their current treatment for 12 weeks. Receives: Dietary Supplement: Probiotic group |
| Control group | No intervention | Patients in the control group were not given any additional treatment and were allowed to continue their routine antidiabetic treatment for 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of probiotics on inflammatory markers
hs-CRP
Measured: From enrollment to the end of treatment at 12 weeks
Efficacy of probiotics on inflammatory markers
Ceruloplasmin
Measured: From enrollment to the end of treatment at 12 weeks
Efficacy of probiotics on antioxydant systems
Glutathion
Measured: From enrollment to the end of treatment at 12 weeks
Efficacy of probiotics on antioxydant systems
malondialdehyde
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (6)
Efficacy of probiotics on glucose metabolism
Postprandial Blood Glucose
Measured: From enrollment to the end of treatment at 12 weeks
Efficacy of probiotics on glucose metabolism
Fasting Blood Glucose
Measured: From enrollment to the end of treatment at 12 weeks
Efficacy of probiotics on glucose metabolism
HbA1c
Measured: From enrollment to the end of treatment at 12 weeks
Efficacy of probiotics on lipid metabolism
LDL Cholesterol
Measured: From enrollment to the end of treatment at 12 weeks
Efficacy of probiotics on lipid metabolism
HDL Cholesterol
Measured: From enrollment to the end of treatment at 12 weeks
Efficacy of probiotics on lipid metabolism
Triglyceride
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Jul 2020
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
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 Diabetes Mellitus (Type 2)Studies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were allocated sequentially according to order of presentation (alternate allocation). According to the order of presentation to the outpatient clinic, the first patient who met the inclusion criteria was included in the probiotic group and the second patient who presented to the outpatient clinic was included in the control group. Patients in the intervention group were given a probiotic supplement containing Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium lactis and Lactobacillus paracasei, each containing 1.25 billion live microorganisms, without vitamins and minerals, twice a day in addition to their current treatment for 12 weeks (Probiotic group). Patients in the control group were not given any additional treatment and were allowed to continue their antidiabetic treatment for 12 weeks (Control group).
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asli Kilavuz, Ege University
- Investigators
- İskender İnce, Assoc. Prof., Study chair, Coordinator of Scientific Research Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330388
- Sponsor's protocol ID
- 18-4.1/67
- Other IDs
- TGA-2020-20200
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kilavuz A, Zorbozan O, Yildirim Simsir I, Turgay N, Yilmaz O. Effects of multistrain probiotics on metabolic biomarkers, inflammation, and antioxidant system in patients with type 2 diabetes mellitus: a prospective controlled trial in Turkiye. BMC Nutr. 2026 May 21;12(1):132. doi: 10.1186/s40795-026-01354-9.
PubMed 42169191
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Probiotics on Metabolic Biomarkers, Inflammation, and the Antioxidant System in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07330388
- Acronym / sponsor ID
- 18-4.1/67
- Conditions
- Diabetes Mellitus (Type 2), Inflammation, Probiotics, Antioxidant Effect, Glucose Metabolism, Lipid Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 9 Jan 2026 (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.
Adult-onset diabetes is a disease characterized by high blood glucose levels and is one of the leading causes of cardiovascular disease, blindness, end-stage renal failure, and hospitalization. Recent studies support the idea that bacteria found in the gut may play an important role in the development and progression of diabetes. Changes in the gut bacterial environment can affect blood glucose and blood lipids. A increasing number of recent studies have shown that probiotics can alter the gut bacterial environment and reduce blood glucose and blood lipids. The aim of this study is to investigate the effects of probiotics, administered in addition to your current medications, on blood glucose and blood lipids.
Detailed description
Participants aged 35-65 years diagnosed with T2DM were allocated sequentially according to order of presentation to either probiotic group (n=39) or control group (n=38). The intervention group received a multi-strain probiotic supplement containing Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium lactis and Lactobacillus paracasei, twice daily for 12 weeks, while the control group continued standard care. This study evaluated anthropometric measurements, eating attitudes, dietary frequency, quality of life, and physical activity. Biochemical analyses included glycemic control, lipid profiles, inflammation markers (high-sensitivity C-Reactive Protein, Ceruloplasmin), and oxidative stress markers (Malondialdehyde, Glutathione).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were allocated sequentially according to order of presentation (alternate allocation). According to the order of presentation to the outpatient clinic, the first patient who met the inclusion criteria was included in the probiotic group and the second patient who presented to the outpatient clinic was included in the control group. Patients in the intervention group were given a probiotic supplement containing Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium lactis and Lactobacillus paracasei, each containing 1.25 billion live microorganisms, without vitamins and minerals, twice a day in addition to their current treatment for 12 weeks (Probiotic group). Patients in the control group were not given any additional treatment and were allowed to continue their antidiabetic treatment for 12 weeks (Control group).
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Dietary Supplement: Probiotic groupPatients in the intervention group were given a probiotic supplement containing Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium lactis and Lactobacillus paracasei, each containing 1.25 billion live microorganisms, without vitamins and minerals, twice a day in addition to their current treatment for 12 weeks. |
| Control group | No intervention | –Patients in the control group were not given any additional treatment and were allowed to continue their routine antidiabetic treatment for 12 weeks |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 35-65 years
- Previously diagnosed with T2DM
- Volunteering to participate in this study.
Key exclusion criteria (4 listed)
- Use of any systemic antibiotics, multivitamins, minerals, herbal medicines, prebiotic, probiotic and postbiotic supplements in the last 3-6 months
- Having a diagnosis of any inflammatory bowel disease, severe renal dysfunction or hepatic dysfunction, immunodeficiency diseases, acute infection, rheumatoid arthritis, cancer history
- history of alcohol abuse or drug dependence,
- pregnant or lactating women
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 |
|---|---|---|
| Probiotic groupPatients in the intervention group were given a probiotic supplement containing Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium lactis and Lactobacillus paracasei, each containing 1.25 billion live microorganisms, without vitamins and minerals, twice a day in addition to their current treatment for 12 weeks (Probiotic group). Patients in the control group were not given any additional treatment and were allowed to continue their routine antidiabetic treatment for 12 weeks (Control group). | Dietary supplement | Probiotic group |
Primary outcome
Efficacy of probiotics on inflammatory markers
Time frame: From enrollment to the end of treatment at 12 weeks
hs-CRP
Efficacy of probiotics on inflammatory markers
Time frame: From enrollment to the end of treatment at 12 weeks
Ceruloplasmin
Efficacy of probiotics on antioxydant systems
Time frame: From enrollment to the end of treatment at 12 weeks
Glutathion
Efficacy of probiotics on antioxydant systems
Time frame: From enrollment to the end of treatment at 12 weeks
malondialdehyde
6 secondary outcomes
Efficacy of probiotics on glucose metabolism
Time frame: From enrollment to the end of treatment at 12 weeks
Efficacy of probiotics on glucose metabolism
Time frame: From enrollment to the end of treatment at 12 weeks
Efficacy of probiotics on glucose metabolism
Time frame: From enrollment to the end of treatment at 12 weeks
Efficacy of probiotics on lipid metabolism
Time frame: From enrollment to the end of treatment at 12 weeks
Efficacy of probiotics on lipid metabolism
Time frame: From enrollment to the end of treatment at 12 weeks
Efficacy of probiotics on lipid metabolism
Time frame: From enrollment to the end of treatment at 12 weeks
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 9 Jan 2026.
- Derived from this study: PubMed 42169191Kilavuz A, Zorbozan O, Yildirim Simsir I, Turgay N, Yilmaz O. Effects of multistrain probiotics on metabolic biomarkers, inflammation, and antioxidant system in patients with type 2 diabetes mellitus: a prospective controlled trial in Turkiye. BMC Nutr. 2026 May 21;12(1):132. doi: 10.1186/s40795-026-01354-9.
- 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.
İskender İnce, Assoc. Prof. study chair
Coordinator of Scientific Research Projects
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic group in people with Diabetes Mellitus (Type 2) and Inflammation, run by Ege University at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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 9 Jan 2026. 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 Turkey (Türkiye). 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. 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?
Efficacy of probiotics on inflammatory markers (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 4 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 NCT07330388, 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 9 Jan 2026.