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

University of Banja Luka

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Other: Triple therapy - metformin, probiotic and ursodeoxycholic acid (Bilexin®, Bosnalijek); Other: Metformin combined with probiotic (Normia® Jadran Galenski Laboratory) supplementation; Other: Metformin Monotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07072949

PRUDCAT2DM

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

The Metformin Group

Other group

Treatment:

Other: Metformin Monotherapy

The Metformin/Probiotic Group

Other group

Treatment:

Other: Metformin combined with probiotic (Normia® Jadran Galenski Laboratory) supplementation

The Metformin/Probiotic/UDCA Group

Other group

Treatment:

Other: Triple therapy - metformin, probiotic and ursodeoxycholic acid (Bilexin®, Bosnalijek)