Efficacy Heterogeneity of Lactobacillus Paracasei LC19 on Type 2 Diabetes

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: Lactobacillus paracasei LC19 Intervention

Detailed Description

This is a single-center, open-label, single-arm study designed to investigate inter-individual variability in glycemic response to Lactobacillus paracasei LC19 (LC19) in patients with newly diagnosed type 2 diabetes (T2D). A total of 70 eligible participants with newly diagnosed T2DM will be enrolled. All participants will receive oral LC19 strain powder (2 packets per day, 2 g per packet) for 12 weeks. No placebo or active comparator will be included in this study.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jia Liu; Phone Number: 010-85231710; Email: liujia0116@126.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100020
      • Beijing Chao-Yang Hospital, Capital Medical University
      • Contact: Xiaoyu Ding; Phone Number: 010-85231711; Email: dxycy0828@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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, and risks 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 latent autoimmune diabetes), special type diabetes, or secondary diabetes (such as acromegaly or Cushing's syndrome, etc.)
• Subjects with acute diabetic complications such as diabetic ketoacidosis or diabetic hyperosmolar 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 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 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 pregnant or in lactation, or those planning to become pregnant or impregnate during or within 3 months after the study 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 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 3 months before secreening
• Subjects with lactose intolerance, known or suspected allergy to probiotics used in experiments, history of drug allergies or allergic diseases
• Subjects with weight fluctuations ≥ 5kg in the past 3 months or planning to take medication to control weight during the study period
• 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 have participated in any other clinical study in the past 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lactobacillus paracasei LC19 supplementation; All participants will receive oral Lactobacillus paracasei LC19 powder (2g/packet, 2 packets/day) for 12 weeks.	Dietary supplement: Lactobacillus paracasei LC19 Intervention; All participants will receive oral Lactobacillus paracasei LC19 powder (2 g/packet, 2 packets/day) for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c change	Changes in HbA1c from baseline to week 12 during follow-up	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose tolerance	Changes in blood glucose levels during OGTT (at 0, 30, 60, 120 min) from baseline to week 4 and week 12	12 weeks
Plasma GLP-1 change	Changes in GLP-1 levels during OGTT (at 0, 30, 60, 120 min) from baseline to week 4 and week 12	12 weeks
BMI change	Change in BMI from baseline to week 4, week 8, and week 12	12 weeks
Weight change	Change in weight from baseline to week 4, week 8, and week 12	12 weeks
Alteration of gut microbiome	Fecal metagenomics sequencing from baseline to 12-week follow-up	12 weeks

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital
• Investigators: Principal Investigator: Guang Wang, Beijing Chao Yang Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: April 3, 2026
• First Submitted That Met QC Criteria: April 3, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2026-DM-Lp

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No