The Impact of Ursodeoxycholic Acid and Probiotics on Metabolic Outcomes in Type 2 Diabetic Patients Taking Metformin
NCT ID: NCT07072949
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
90 participants
INTERVENTIONAL
2023-01-03
2024-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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The Metformin Group
Metformin Monotherapy
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.
The Metformin/Probiotic Group
Metformin combined with probiotic (Normia® Jadran Galenski Laboratory) supplementation
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.
The Metformin/Probiotic/UDCA 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.
Interventions
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Metformin Monotherapy
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) supplementation
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)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* History or diagnosis of gastrointestinal diseases
* Chronic kidney disease
* Valvular heart disease
* Pregnancy
* Presence of any acute infection
25 Years
ALL
No
Sponsors
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University of Banja Luka
OTHER
Responsible Party
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Locations
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Public Health Institution Dom zdravlja Banja Luka
Banja Luka, Republika Srpska, Bosnia and Herzegovina
Countries
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Other Identifiers
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PRUDCAT2DM
Identifier Type: -
Identifier Source: org_study_id
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