The role of Probiotics in Improving Diabetes Control in Newly DiagnosedÂ Patients

Role of oral probiotics as an adjunct to metformin in enhancing glycemic control in type 2 diabeticsâ?? A cluster randomized trial from central India. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/087230

Enrollment

120

Registered

2025-05-21

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: probiotic sachets: one probiotic and prebiotic sachet of 1gm once a daily 30 minutes before meal along with their prescribed metformin dosage, for 12 weeks. Control Intervention1: METFO

Eligibility

Inclusion criteria

Inclusion criteria: Newly diagnosed adult diabetes mellitus type 2 patients on metformin mono-therapy. Patients who are willing to give consent

Exclusion criteria

Exclusion criteria: Patients with chronic gastrointestinal disease. Mental incapacity to give consent Pregnant and lactating women. Type 1 Diabetes mellitus patients. Patients who are on other anti-diabetic drugs than metformin. Patients who are on other alternative diabetic drugs

Design outcomes

Primary

Measure	Time frame
HBA1c, fasting blood glucose, and postprandial blood glucoseTimepoint: at endline 12 weeks	—

Secondary

Measure	Time frame
Effect of probiotics on gastrointestinal adverse effects caused by metformin (using GSRS scale).Timepoint: after 12 weeks ;Effect of probiotics on quality of life (using the QOLID scale). Timepoint: after 12 weeks	—

Countries

India

Contacts

Public ContactDr Sushil Marotrao Shinde

GOVERNMENT MEDICAL COLLEGE NAGPUR

saritawadhva@yahoo.com08600670684

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026