Efficacy of Lactobacillus Paracasei LC19 on Type 2 Diabetes

Efficacy of Lactobacillus Paracasei LC19 on Newly Diagnosed Type 2 Diabetes

This is a randomized, double-blind, placebo-controlled clinical trial. The objective of this trial is to determine whether Lactobacillus paracasei LC19 supplementation has a positive effect on glucose lowering in patients with type 2 diabetes (T2D).

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: Lactobacillus paracasei LC19 supplementation; Dietary supplement: Placebo probiotic milk powder

Detailed Description

In this trial, approximately 60 drug-naive patients with newly diagnosed Type 2 Diabetes (T2D) will be recruited. Laboratory evaluations will be conducted on the subjects to confirm their eligibility before randomization. After the screening, eligible subjects will be randomly assigned in a 1:1 ratio to either the Lactobacillus paracasei LC19 supplementation group or the placebo group during the randomization visit. They will then enter a 12-week double-blind treatment period.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jia Liu, MD; Phone Number: 010-85231710; Email: liujia0116@126.com
• Study Contact Backup: Name: Xiaoyu Ding, MD; Phone Number: 010-85231711; Email: dxycy0828@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100020
      • Recruiting
      • Beijing CHAO-YANG Hospital, Capital Medical University
      • Contact: Jia Liu, MD; Phone Number: liujia0116@126 010-8523161710; 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: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lactobacillus paracasei LC19 supplementation	Dietary supplement: Lactobacillus paracasei LC19 supplementation; Orally administered Lactobacillus paracasei LC19 strain product, in addition to lifestyle intervention. This product is a probiotic milk powder, and the Lactobacillus paracasei LC19 strain is capable of producing high levels of tryptophan-conjugated cholic acid (Trp-CA)( 25g/packet, 2 packets/day).
Placebo Comparator: Placebo probiotic milk powder	Dietary supplement: Placebo probiotic milk powder; Orally administered placebo probiotic milk powder, in addition to lifestyle intervention. The placebo probiotic strain also belongs to Lactobacillus paracasei species, but does not produce Trp-CA. These products have the same color, odor, appearance, and packaging (25g/packet, 2 packets/day).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c change	Changes in HbA1c from baseline at12 weeks during follow-up	From enrollment to the end of treatment at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fasting blood glucose change	Changes in fasting blood glucose from baseline at 4, 8, and 12 weeks during follow-up	From baseline at 4, 8, and 12 weeks during follow-up
Glycated albumin change	Changes in glycated albumin from baseline at 4 and 12 weeks during follow-up	From baseline at 4 and 12 weeks during follow-up
Glycemic achieving rate	Glycemic achieving rate with HbA1c<6.5% at 12-week follow-up	From enrollment to the end of treatment at 12 weeks
Glucose tolerance	Changes in blood glucose levels (at 0, 30, 60, and 120 minutes during OGTT) from baseline at 4 and 12 weeks during follow-up	From baseline at 4 and 12 weeks during follow-up
Insulin change	Changes in insulin levels (at 0, 30, 60, and 120 minutes during OGTT) from baseline at 4 and 12 weeks during follow-up	From baseline at 4 and 12 weeks during follow-up
Plasma GLP-1 change	Changes in GLP-1 levels (at 0, 30, 60, and 120 minutes during OGTT) from baseline at 4 and 12 weeks during follow-up	From baseline at 4 and 12 weeks during follow-up
BMI change	Changes in BMI from baseline at 4, 8, and 12 weeks during follow-up	From baseline at 4, 8, and 12 weeks during follow-up
Alteration of fecal metabolites	Fecal metabolites analysis from baseline to 12-week follow-up	From enrollment to the end of treatment at 12 weeks
Alteration of gut microbiome	Fecal metagenomics sequencing from baseline to 12-week follow-up	From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2024
• Primary Completion (Estimated): October 14, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 5, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: 2024-DM-Lp

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No