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NCT Number: NCT07072949

The Impact of Ursodeoxycholic Acid and Probiotics on Metabolic Outcomes in Type 2 Diabetic Patients Taking Metformin

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Public Health Institution Dom zdravlja Banja Luka

Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Diagnosis of type 1 diabetes mellitus
  • History or diagnosis of gastrointestinal diseases
  • Chronic kidney disease
  • Valvular heart disease
  • Pregnancy
  • Presence of any acute infection

Treatment and study plan

Metformin Monotherapy

Other

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

Other

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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 (%)

  4. 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 (%)

Secondary outcomes

  1. Change in total cholesterol from baseline to week 4

    Time frame: Baseline and after 4 weeks of intervention

    Assessment of total serum cholesterol levels to evaluate lipid profile modulation in response to intervention.

    Unit of measure: mmol/L

  2. Change in LDL cholesterol from baseline to week 4

    Time frame: Baseline and after 4 weeks of intervention

    Measurement of low-density lipoprotein cholesterol to assess cardiovascular risk changes.

    Unit of measure: mmol/L

  3. Change in HDL cholesterol from baseline to week 4

    Time frame: Baseline and after 4 weeks of intervention

    Measurement of high-density lipoprotein cholesterol to evaluate potential improvement in lipid metabolism.

    Unit of measure: mmol/L

  4. Change in triglycerides from baseline to week 4

    Time frame: Baseline and after 4 weeks of intervention

    Serum triglyceride levels will be measured to observe any changes due to intervention.

    Unit of measure: mmol/L

  5. Change in C-Reactive Protein (CRP) from baseline to week 4

    Time frame: Baseline and after 4 weeks of intervention

    C-reactive protein will be quantified to assess the anti-inflammatory potential of the interventions.

    Unit of measure: mg/L

Sponsors and collaborators

Lead sponsor

University of Banja Luka

Other

Registry information

Official study title

The Impact of Ursodeoxycholic Acid and Probiotics on Metabolic Outcomes in Type 2 Diabetic Patients Taking Metformin: a Randomized, Double-blind Clinical Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2025
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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