Efficacy of Lactobacillus Paracasei LC19 on Type 2 Diabetes

Inclusion Criteria:

• Age 18-65 years, both genders eligible

• Drug-naive patients with newly diagnosed type 2 diabetes

• Subjects with screening HbA1c ≥ 7.0% and ≤ 9.0%

• Subjects understand the nature, significance, potential benefits, inconvenience, andrisks and procedure of the study, and voluntarily sign the informed consent form

Exclusion Criteria:

• Other types of diabetes except T2D: type 1 diabetes (including adult latentautoimmune diabetes), special type diabetes, or secondary diabetes (such asacromegaly or Cushing's syndrome, etc.)

• Subjects with acute diabetic complications such as diabetic ketoacidosis or diabetichyperosmolar coma in the past 6 months

• Subjects with history of hypoglycemia in the past 6 months

• Subjects with history of New York Heart Association class (NYHA) grade of heartfunction ≥ III or serious cardiovascular diseases (myocardial infarction, or withthe history of cardiac interventional therapy or stent implantation, valve diseaseor valve repair, unstable angina, transient ischemic attack or stroke) within 6months before the screening period

• Subjects with history of chronic active hepatitis and/or severe liver dysfunction,renal dysfunction, and thyroid dysfunction

• Subjects with a medical history of malignant tumor

• Subjects with history of gastrointestinal diseases that affect food digestion andabsorption (such as severe diarrhea, constipation, irritable bowel syndrome,inflammatory bowel disease, active gastrointestinal ulcers, acute cholecystitis,etc.) or with a history of intestinal resection or other gastrointestinal surgery (such as cholecystectomy) within one year before the screening period

• Subjects with history of surgery, or severe trauma in the past 6 months, or planningto undergo surgery during the study period

• Subjects suffering from severe infections, severe anemia, or neutropenia

• Subjects pregnant or in lactation, or those planning to become pregnant orimpregnate during or within 3 months after the study period

• Subjects with history of receiving immunosuppressants, steroids, anti diarrhealdrugs, antibiotics, lipid-lowering drugs, or other gastrointestinal motilitymedications within the past 3 months;

• Subjects using other medications that can affect blood glucose in the past 3 months

• Subjects with consumption of other probiotic or prebiotic products in the past 3months before secreening

• Subjects with lactose intolerance, known or suspected allergy to probiotics used inexperiments, history of drug allergies or allergic diseases

• Subjects with weight fluctuations ≥ 5kg in the past 3 months or planning to takemedication to control weight during the study period

• Subjects with history of mental illness or epilepsy, or taking antidepressantmedications

• Subjects with history of alcohol abuse (for men, alcohol consumption exceeding 40grams per day and for women, exceeding 20 grams per day)

• Subjects have participated in any other clinical study in the past 3 months