NCT07072949CompletedPhase 1
The Impact of Ursodeoxycholic Acid and Probiotics on Metabolic Outcomes in Type 2 Diabetic Patients Taking Metformin
The Impact of Ursodeoxycholic Acid and Probiotics on Metabolic Outcomes in Type 2 Diabetic Patients Taking Metformin: a Randomized, Double-blind Clinical Trial
Source: ClinicalTrials.gov · Last updated 18 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 90 (actual)
- First submitted
- 7 Jul 2024
- Start date
- 3 Jan 2023
- Primary completion date
- 31 Jan 2024
- Lead sponsor
- University of Banja Luka
- Diseases
- Type 2 diabetes
- NCT number
- NCT07072949
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 90
- From 3 Jan 2023 to the primary completion date, 31 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosis of type 1 diabetes mellitus
- History or diagnosis of gastrointestinal diseases
- Chronic kidney disease
- Valvular heart disease
- Presence of any acute infection
Other
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 25 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Public Health Institution Dom zdravlja Banja Luka Coordinator of this site? Confirm its status | Banja Luka | Bosnia and Herzegovina | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.