Probiotic VSL#3 in patients with Type-1 Diabetes Mellitus

Effect of oral administration of probiotic preparation VSL#3, a clinically safe mixture of 8 strains of viable live, lyophilized lactic acid bacteria, on the metabolic control in individuals with type-1 diabetes mellitus (T1DM); a randomized, double-blind, placebo controlled trial â?? A pilot study

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/11/003125

Enrollment

Registered

2012-11-20

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Type 1 Diabetes Mellitus

Interventions

Intervention1: VSL#3 Capsules: 6 capsules orally thrice daily (two capsules after each meal), for 16 weeks. Each Capsule contains 112.5 Billion CFU of live, lyophilized bacteria Control Intervention1

Eligibility

Inclusion criteria

Inclusion criteria: Patients with T1DM 18yrs of age or more(upto 65 yrs) Duration of diabetes < 5 years

Exclusion criteria

Exclusion criteria: 1. Patients with any other forms of diabetes 2. Pregnant and lactating women 3. Patients with chronic renal or chronic liver disease 4. Patients with any acute infective or systemic inflammatory illness 5. Illiterate patients 6. Patients unable to provide written informed consent 7. Patients with serious diseases

Design outcomes

Primary

Measure	Time frame
Change in glycosylated hemoglobin levelsTimepoint: 16 weeks	—

Secondary

Measure	Time frame
CGMS Results If primary endpoints are met, cytokine ((IL-10, IL-1Beta, TNF-alpha, IFN-gamma, TGF-Beta) assessments would be doneTimepoint: 16 wks	—

Countries

India

Contacts

Public ContactDr Nikhil Tandon

AIIMS

nikhil_tandon@hotmail.com011-26593433

Outcome results

None listed

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