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A randomized, double-blind, placebo-controlled intervention study to evaluate the efficacy and safety of probiotics HAC01 in patients with type 2 diabetes

A randomized, double-blind, placebo-controlled intervention study to evaluate the efficacy and safety of probiotics HAC01 in patients with type 2 diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009773
Enrollment
50
Registered
2024-09-09
Start date
2024-08-23
Completion date
Unknown
Last updated
2024-11-14

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

Conditions

None listed

Interventions

Dietary Supplement : Subjects will be randomized to receive Lactiplantibacillus plantarum HAC01 or placebo. Subjects will orally self-adminster Lactiplantibacillus plantarum HAC01 or placebo, once, 1

Sponsors

Chungnam National University Sejong Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adults who are at least 19 years and less than 75 years as of the date written consent is obtained 2) Those who satisfy both at screening ? Diagnosed with diabetes and are living with it ? Fasting blood glucose are at least 126 mg/dl and HbA1c are at least 6.5% and less than 7.0%. 3) Agree to maintain a diet and exercise regimen for at least 3 months

Exclusion criteria

Exclusion criteria: 1) Type 1 diabetes mellitus 2) Patients with uncontrolled hyperglycemia: Fasting blood glucose are at least 250 mg/dl, random fasting blood glucose is continuously at least 300 mg/dl, A1c are at least 10% 3) Have lost at least 10% of body weight in the last 3 months

Design outcomes

Primary

MeasureTime frame
Post prandial 2 hours blood sugar test

Secondary

MeasureTime frame
Fasting plasma glucose

Countries

Korea, Republic of

Contacts

Public ContactKyong Hye Joung

Chungnam National University Sejong Hospital

babehorse@cnuh.co.kr+82-44-995-4741

Outcome results

None listed

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