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Influence of Lactobacillus paracasei HII01 Supplementation on Glycaemia and Inflammatory biomarkers in Type 2 Diabetes: A Randomized Clinical Trial

Influence of Lactobacillus paracasei HII01 Supplementation on Glycaemia and Inflammatory biomarkers in Type 2 Diabetes: A Randomized Clinical Trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20201223007
Enrollment
Unknown
Registered
2020-12-23
Start date
2019-05-10
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Health Condition= Participants who no have side effects from probiotic such as diarrhea&#44

Interventions

Participants in placebo group received corn starch 10 mg/day during the 12 weeks of intervention. ,Participants in probiotic group received a probiotic L. paracasei HII01 50 × 109 CFU/day during
Placebo group,Probiotic group

Sponsors

Faculty of Pharmacy, Chiang Mai University
Lead Sponsor
Faculty of Medicine&#44
Collaborator
Chiang Mai University
Collaborator

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Type 2 diabetic patients will be either sex (male or female) between the ages 20 to 70 years. 2) Patients who do not take antibiotic drugs for 14 days before starting of the study. 3) Patients who can listen, speak, write and read Thai language.

Exclusion criteria

Exclusion criteria: 1) Pregnant or nursing patients 2) Smokers 3) Patients with abnormal liver function test, ALT > 55 U/L, AST > 34 U/L, ALP > 125 U/L 4) Patients with abnormal renal function test, GFR ≤ 60 ml/min 5) Patients with history of malignant 6) Patients with micro and macro vascular complications 7) Patients with uncontrollable emotions which approved by the behavioral and cognitive test and physician 8) Patients with thyroid disorder or the endocrine metabolic disorders 9) Patients with chronic alcoholic or frequency ≥ 2 times/weeks

Design outcomes

Primary

MeasureTime frame
Gut microbiota composition change 12 weeks Real-Time PCR of feces bacteria in feces

Secondary

MeasureTime frame
Blood biochemical that related with type 2 diabetes 12 weeks commercial colorimetric kit, commercial ELISA kit,

Countries

Thailand

Contacts

Public ContactNarissara Lailerd

Faculty of Medicine, Chiang Mai University

narissara.lailerd@cmu.ac.th05393 5362

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026