To check the effect of probiotics in type 2 diabetic patient

A randomized double blinded placebo controlled comparative clinical study to evaluate the safety and efficacy of probiotics in the management of type 2 diabetic patients. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/09/073348

Enrollment

100

Registered

2024-09-04

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

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: Glimepiride 1/2 mg + Metformin 500 mg + Probiotics: One capsule/tablet twice daily orally for 90 days Control Intervention1: Glimepiride 1/2 mg + Metformin 500 mg + Placebo: One capsule

Eligibility

Inclusion criteria

Inclusion criteria: 1.Willing and able to provide written informed consent prior to performing study procedures. 2. Type II diabetic patients between the age of 18-65 years. 3. Males or females; females must be non-pregnant / non-lactating and practicing adequate birth control measures if not menopausal. 4. Participants with HbA1c 6.5 - 10. 5. Patient should not have participated in any other clinical trial during the past 3 months.

Exclusion criteria

Exclusion criteria: 1. Type 1 diabetes mellitus and pre diabetics. 2. Concomitant gastrointestinal disorders (i.e., irritable bowel syndrome, inflammatory bowel disease and coeliac disease) 3. Recent use (within the previous 4 weeks) of antibiotics and dietary supplements (fish oil, probiotics, prebiotics, multivitamins, minerals, nutraceuticals and herbal preparations) 4. K/C/o cardiovascular or renal complications. 5. Patients who are on immunomodulatory or immunosuppressants for any other illness. 6. History of allergy to probiotics. 7. History of drug or alcohol abuse.

Design outcomes

Primary

Measure	Time frame
1. Fasting and post prandial blood sugar levels. (Time points: Day 0, Day 30, Day 60 and Day 90) 2. HbA1c levels (Time points: Day 0 and Day 90) 3. Overall global status of improvement and quality of life (Time points: Day 0 and Day 90) 4. Change in the anthropometrics and blood pressure measurements from baseline to post study (Time points: Day 0 and Day 90) 5. Change in lipid profile from baseline to post study (Time points: Day 0 and Day 90)Timepoint: Day 0, Day 30, Day 60 and Day 90	—

Measure

Time frame

1. Fasting and post prandial blood sugar levels. (Time points: Day 0, Day 30, Day 60 and Day 90) 2. HbA1c levels (Time points: Day 0 and Day 90) 3. Overall global status of improvement and quality of life (Time points: Day 0 and Day 90) 4. Change in the anthropometrics and blood pressure measurements from baseline to post study (Time points: Day 0 and Day 90) 5. Change in lipid profile from baseline to post study (Time points: Day 0 and Day 90)Timepoint: Day 0, Day 30, Day 60 and Day 90

—

Secondary

Measure	Time frame
? Each patient will undergo a complete physical examination, blood sugar level assessment before enrolment in the study. ? Other blood parameters like CBC, RFT, LFT and lipid profile will be done on Day 0 and Day 90 for safety purpose. ? ADR monitoringTimepoint: Day 0 and Day 90	—

Countries

India

Contacts

Public ContactDr Gayathri Sivakumar

Ki3 Private Limited

saheerose@gmail.com9443627722

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026