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

NCT07072949 | Completed Phase 1

• 1 other identifier: PRUDCAT2DM
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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, 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

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  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 (%)

  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 (%)

  After 4 weeks of intervention

Secondary Outcomes (5)

• Change in total cholesterol from baseline to week 4

  Baseline and after 4 weeks of intervention

• Change in LDL cholesterol from baseline to week 4

  Baseline and after 4 weeks of intervention

• Change in HDL cholesterol from baseline to week 4

  Baseline and after 4 weeks of intervention

• Change in triglycerides from baseline to week 4

  Baseline and after 4 weeks of intervention

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

  Baseline and after 4 weeks of intervention

Study Arms (3)

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)

Interventions

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.

The Metformin Group

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.

The Metformin/Probiotic Group

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.

The Metformin/Probiotic/UDCA Group

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Banja Luka: lead

Study Sites (1)

Public Health Institution Dom zdravlja Banja Luka

Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Probiotics; Dietary Supplements; Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: July 7, 2024
• First Posted: July 18, 2025
• Study Start: January 3, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: July 18, 2025

Record last verified: 2025-07

Locations

BO (1)