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

NCT07072949 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-07-18

No results posted yet for this study

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

Interventions

OTHER

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.

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • University of Banja Luka

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-03
Primary Completion
2024-01-31
Completion
2024-01-31

Countries

  • Bosnia and Herzegovina

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07072949 on ClinicalTrials.gov