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

Phase 1

Completed

• Conditions: Health Condition= Participants who no have side effects from probiotic such as diarrhea, flatulence or skin rash.; Lactobacillus paracasei; Probiotics; Type 2 diabetes mellitus; Gut microbiota; Antihyperglycemia

• Registration Number: TCTR20201223007
• Lead Sponsor: Faculty of Pharmacy, Chiang Mai University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-08-10
• Study Start: 2020-12-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gut microbiota composition change 12 weeks Real-Time PCR of feces bacteria in feces

Secondary Outcome Measures

Name	Time	Method
Blood biochemical that related with type 2 diabetes 12 weeks commercial colorimetric kit, commercial ELISA kit,