Lactobacillus paracasei LC19 probiotic in people newly diagnosed with type 2 diabetes
Tests how blood sugar responds to Lactobacillus paracasei LC19 in newly diagnosed type 2 diabetes.
Plain-language title generated from the registry record
Registry title: Efficacy Heterogeneity of Lactobacillus Paracasei LC19 on Type 2 Diabetes
Key facts
- Where
- Beijing, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07520305, who can take part
Where in China
- Beijing Chao-Yang Hospital, Capital Medical UniversityBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Beijing Chao Yang Hospital
- Trial code
- NCT07520305
- Record updated
- 9 April 2026
- Original description
This is a single-arm study to investigate the heterogeneity of glycemic response to Lactobacillus paracasei LC19 in patients with newly diagnosed type 2 diabetes. Participants will receive LC19 for 12 weeks, and changes in glycemic control will be evaluated.Read full original descriptionShow less
A Study of the Efficacy Heterogeneity of Lactobacillus Paracasei LC19 Intervention in Patients With Newly Diagnosed Type 2 Diabetes
This is a single-arm study to investigate the heterogeneity of glycemic response to Lactobacillus paracasei LC19 in patients with newly diagnosed type 2 diabetes. Participants will receive LC19 for 12 weeks, and changes in glycemic control will be evaluated.
Inclusion: 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, and risks and procedure of the study, and voluntarily sign the informed consent form.
Exclusion: Subjects with history of New York Heart Association class (NYHA) grade of heart function ≥ III or serious cardiovascular diseases (myocardial infarction, or with the history of cardiac interventional therapy or stent implantation, valve disease or valve repair, unstable angina, transient ischemic attack or stroke) within 6 months before the screening period; Subjects with history of receiving immunosuppressants, steroids, anti diarrheal drugs, antibiotics, lipid-lowering drugs, or other gastrointestinal motility medications within the past 3 months; Subjects with consumption of other probiotic or prebiotic products in the past 3 months before secreening; Subjects with weight fluctuations ≥ 5kg in the past 3 months or planning to take medication to control weight during the study period; Other types of diabetes except T2D: type 1 diabetes (including adult latent autoimmune diabetes), special type diabetes, or secondary diabetes (such as acromegaly or Cushing\'s syndrome, etc.); Subjects with history of hypoglycemia in the past 6 months; 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 and absorption (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 planning to undergo surgery during the study period; Subjects suffering from severe infections, severe anemia, or neutropenia; Subjects with lactose intolerance, known or suspected allergy to probiotics used in experiments, history of drug allergies or allergic diseases; Subjects with history of mental illness or epilepsy, or taking antidepressant medications; Subjects with history of alcohol abuse (for men, alcohol consumption exceeding 40 grams per day and for women, exceeding 20 grams per day); Subjects using other medications that can affect blood glucose in the past 3 months; Subjects with acute diabetic complications such as diabetic ketoacidosis or diabetic hyperosmolar coma in the past 6 months; Subjects pregnant or in lactation, or those planning to become pregnant or impregnate during or within 3 months after the study period; Subjects have participated in any other clinical study in the past 3 months.