Type 2 Diabetes MellitusPhase 1NCT07072949
The Impact of Ursodeoxycholic Acid and Probiotics on Metabolic Outcomes in Type 2 Diabetic Patients Taking Metformin
A Phase 1 study testing Metformin Monotherapy, Metformin combined with probiotic (Normia® Jadran Galenski Laboratory) supplementation and Triple therapy - metformin, probiotic and ursodeoxycholic acid (Bilexin®, Bosnalijek) in people with Type 2 Diabetes Mellitus, run by University of Banja Luka at 1 site in Bosnia and Herzegovina.
Trial summary
A monocentric prospective randomized double-blind controlled study included 90 patients with T2DM on metformin therapy. Patients were randomized into three groups: a metformin group (1000 to 2000 mg daily in two doses), a metformin and probiotic group (metformin + oral probiotic 3x1 capsule), and a metformin… Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Metformin Monotherapy, Metformin combined with probiotic (Normia® Jadran Galenski Laboratory) supplementation and Triple therapy - metformin, probiotic and ursodeoxycholic acid (Bilexin®, Bosnalijek)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- 3 Jan 2023to 31 Jan 2024
- Phase
- Phase 1
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 25 years
- Clinical diagnosis of type 2 diabetes mellitus (T2DM) within the past 12 months
- Body mass index (BMI) ≥ 25 kg/m²
- Stable metformin therapy (1000-2000 mg daily in divided doses)
- No use of probiotics, antibiotics, vitamins, or minerals in the past 30 days
Who cannot join
- Diagnosis of type 1 diabetes mellitus
- History or diagnosis of gastrointestinal diseases
- Chronic kidney disease
- Valvular heart disease
- Pregnancy
- Presence of any acute infection
Trial locations and contacts
1 site in 1 country.
Bosnia and Herzegovina1 site
Public Health Institution Dom zdravlja Banja Luka
Banja Luka, Republika Srpska, 78000
About this study
Official title: The Impact of Ursodeoxycholic Acid and Probiotics on Metabolic Outcomes in Type 2 Diabetic Patients Taking Metformin: a Randomized, Double-blind Clinical Trial
A monocentric prospective randomized double-blind controlled study included 90 patients with T2DM on metformin therapy. Patients were randomized into three groups: a metformin group (1000 to 2000 mg daily in two doses), a metformin and probiotic group (metformin + oral probiotic 3x1 capsule), and a metformin, probiotic and UDCA group (metformin + probiotic 3x1 caps + UDCA 3x1 capsule) for four weeks. Two visits were conducted during the study - at the beginning and the end. Visits involved patient interviews, clinical data collection, anthropometric measurements, biochemical analyses and stool sample analysis for the presence of probiotic culture and UDCA.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Metformin Monotherapy, Metformin combined with probiotic (Normia® Jadran Galenski Laboratory) supplementation, Triple therapy - metformin, probiotic and ursodeoxycholic acid (Bilexin®, Bosnalijek)
- 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.
Metformin MonotherapyOther
Participants in this group (n = 30) received metformin alone, administered in a daily dose of 1000 to 2000 mg divided into two doses, over a period of four weeks.
Metformin combined with probiotic (Normia® Jadran Galenski Laboratory) supplementationOther
Participants (n = 30) received metformin (1000-2000 mg/day, divided in two doses) combined with a probiotic supplement (1 capsule three times daily) over a four-week period.
Triple therapy - metformin, probiotic and ursodeoxycholic acid (Bilexin®, Bosnalijek)Other
Participants in this group (n = 30) were treated with a combination of metformin (1000 - 2000 mg/day), a probiotic (1 capsule three times daily) and ursodeoxycholic acid (UDCA, 1 capsule (250mg) three times daily) for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| The Metformin Group | Other | Not described Receives: Other: Metformin Monotherapy |
| The Metformin/Probiotic Group | Other | Not described Receives: Other: Metformin combined with probiotic (Normia® Jadran Galenski Laboratory) supplementation |
| The Metformin/Probiotic/UDCA Group | Other | Not described Receives: Other: Triple therapy - metformin, probiotic and ursodeoxycholic acid (Bilexin®, Bosnalijek) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting plasma glucose (FPG) from baseline to week 4
Fasting plasma glucose concentration will be measured in mmol/L to assess changes in glycemic control following treatment in each group.
Measured: Baseline and after 4 weeks of intervention
Change in postprandial glucose (PPG) from baseline to week 4
Postprandial plasma glucose concentration will be measured 2 hours after a standardized meal to evaluate treatment efficacy.
Unit of measure: mmol/L
Measured: Baseline and after 4 weeks of intervention
Change in hemoglobin A1c (HbA1c) from baseline to week 4
Glycated hemoglobin (HbA1c) will be measured to assess average blood glucose levels over the preceding 4 weeks.
Unit of measure: Percent (%)
Measured: Baseline and after 4 weeks of intervention
Percentage of participants achieving HbA1c < 7.0% at week 4
Proportion of participants in each group achieving HbA1c values below 7.0%, indicating improved glycemic control.
Unit of measure: Percentage of participants (%)
Measured: After 4 weeks of intervention
Secondary outcomes (5)
Change in total cholesterol from baseline to week 4
Assessment of total serum cholesterol levels to evaluate lipid profile modulation in response to intervention.
Unit of measure: mmol/L
Measured: Baseline and after 4 weeks of intervention
Change in LDL cholesterol from baseline to week 4
Measurement of low-density lipoprotein cholesterol to assess cardiovascular risk changes.
Unit of measure: mmol/L
Measured: Baseline and after 4 weeks of intervention
Change in HDL cholesterol from baseline to week 4
Measurement of high-density lipoprotein cholesterol to evaluate potential improvement in lipid metabolism.
Unit of measure: mmol/L
Measured: Baseline and after 4 weeks of intervention
Change in triglycerides from baseline to week 4
Serum triglyceride levels will be measured to observe any changes due to intervention.
Unit of measure: mmol/L
Measured: Baseline and after 4 weeks of intervention
Change in C-Reactive Protein (CRP) from baseline to week 4
C-reactive protein will be quantified to assess the anti-inflammatory potential of the interventions.
Unit of measure: mg/L
Measured: Baseline and after 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start3 Jan 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A monocentric prospective randomized double-blind controlled study included 90 patients with T2DM on metformin therapy. Patients were randomized into three groups: a metformin group (1000 to 2000 mg daily in two doses), a metformin and probiotic group (metformin + oral probiotic 3x1 capsule), and a metformin, probiotic and UDCA group (metformin + probiotic 3x1 caps + UDCA 3x1 capsule) for four weeks. Two visits were conducted during the study - at the beginning and the end. Visits involved patient interviews, clinical data collection, anthropometric measurements, biochemical analyses and stool sample analysis for the presence of probiotic culture and UDCA.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Banja Luka
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072949
- Sponsor's protocol ID
- PRUDCAT2DM
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2024
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Ursodeoxycholic Acid and Probiotics on Metabolic Outcomes in Type 2 Diabetic Patients Taking Metformin: a Randomized, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT07072949
- Acronym / sponsor ID
- PRUDCAT2DM
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Banja LukaUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 18 Jul 2025 (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.
A monocentric prospective randomized double-blind controlled study included 90 patients with T2DM on metformin therapy. Patients were randomized into three groups: a metformin group (1000 to 2000 mg daily in two doses), a metformin and probiotic group (metformin + oral probiotic 3x1 capsule), and a metformin, probiotic and UDCA group (metformin + probiotic 3x1 caps + UDCA 3x1 capsule) for four weeks. Two visits were conducted during the study - at the beginning and the end. Visits involved patient interviews, clinical data collection, anthropometric measurements, biochemical analyses and stool sample analysis for the presence of probiotic culture and UDCA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- A monocentric prospective randomized double-blind controlled study included 90 patients with T2DM on metformin therapy. Patients were randomized into three groups: a metformin group (1000 to 2000 mg daily in two doses), a metformin and probiotic group (metformin + oral probiotic 3x1 capsule), and a metformin, probiotic and UDCA group (metformin + probiotic 3x1 caps + UDCA 3x1 capsule) for four weeks. Two visits were conducted during the study - at the beginning and the end. Visits involved patient interviews, clinical data collection, anthropometric measurements, biochemical analyses and stool sample analysis for the presence of probiotic culture and UDCA.
| Arm | Type | Receives |
|---|---|---|
| The Metformin Group | Other | Other: Metformin Monotherapy |
| The Metformin/Probiotic Group | Other | Other: Metformin combined with probiotic (Normia® Jadran Galenski Laboratory) supplementation |
| The Metformin/Probiotic/UDCA Group | Other | Other: Triple therapy - metformin, probiotic and ursodeoxycholic acid (Bilexin®, Bosnalijek) |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 25 years
- Clinical diagnosis of type 2 diabetes mellitus (T2DM) within the past 12 months
- Body mass index (BMI) ≥ 25 kg/m²
- Stable metformin therapy (1000-2000 mg daily in divided doses)
- No use of probiotics, antibiotics, vitamins, or minerals in the past 30 days
Key exclusion criteria (6 listed)
- Diagnosis of type 1 diabetes mellitus
- History or diagnosis of gastrointestinal diseases
- Chronic kidney disease
- Valvular heart disease
- Pregnancy
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 |
|---|---|---|
| Metformin MonotherapyParticipants in this group (n = 30) received metformin alone, administered in a daily dose of 1000 to 2000 mg divided into two doses, over a period of four weeks. | Other | The Metformin Group |
| Metformin combined with probiotic (Normia® Jadran Galenski Laboratory) supplementationParticipants (n = 30) received metformin (1000-2000 mg/day, divided in two doses) combined with a probiotic supplement (1 capsule three times daily) over a four-week period. | Other | The Metformin/Probiotic Group |
| Triple therapy - metformin, probiotic and ursodeoxycholic acid (Bilexin®, Bosnalijek)Participants in this group (n = 30) were treated with a combination of metformin (1000 - 2000 mg/day), a probiotic (1 capsule three times daily) and ursodeoxycholic acid (UDCA, 1 capsule (250mg) three times daily) for four weeks. | Other | The Metformin/Probiotic/UDCA Group |
Primary outcome
Change in fasting plasma glucose (FPG) from baseline to week 4
Time frame: Baseline and after 4 weeks of intervention
Fasting plasma glucose concentration will be measured in mmol/L to assess changes in glycemic control following treatment in each group.
Change in postprandial glucose (PPG) from baseline to week 4
Time frame: Baseline and after 4 weeks of intervention
Postprandial plasma glucose concentration will be measured 2 hours after a standardized meal to evaluate treatment efficacy. Unit of measure: mmol/L
Change in hemoglobin A1c (HbA1c) from baseline to week 4
Time frame: Baseline and after 4 weeks of intervention
Glycated hemoglobin (HbA1c) will be measured to assess average blood glucose levels over the preceding 4 weeks. Unit of measure: Percent (%)
Percentage of participants achieving HbA1c < 7.0% at week 4
Time frame: After 4 weeks of intervention
Proportion of participants in each group achieving HbA1c values below 7.0%, indicating improved glycemic control. Unit of measure: Percentage of participants (%)
5 secondary outcomes
Change in total cholesterol from baseline to week 4
Time frame: Baseline and after 4 weeks of intervention
Change in LDL cholesterol from baseline to week 4
Time frame: Baseline and after 4 weeks of intervention
Change in HDL cholesterol from baseline to week 4
Time frame: Baseline and after 4 weeks of intervention
Change in triglycerides from baseline to week 4
Time frame: Baseline and after 4 weeks of intervention
Change in C-Reactive Protein (CRP) from baseline to week 4
Time frame: Baseline and after 4 weeks of intervention
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 18 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Metformin Monotherapy, Metformin combined with probiotic (Normia® Jadran Galenski Laboratory) supplementation and Triple therapy - metformin, probiotic and ursodeoxycholic acid (Bilexin®, Bosnalijek) in people with Type 2 Diabetes Mellitus, run by University of Banja Luka at 1 site in Bosnia and Herzegovina.
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 6 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 18 Jul 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 Bosnia and Herzegovina. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in fasting plasma glucose (FPG) from baseline to week 4 (time frame: Baseline and after 4 weeks of intervention). 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?
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 18 Jul 2025.