Efficacy of Lactobacillus Paracasei LC19 on Type 2 Diabetes

NCT ID: NCT06639425

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-12
• Study Completion Date: 2026-12-31

Brief Summary

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).

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lactobacillus paracasei LC19 supplementation

Group Type: EXPERIMENTAL

Lactobacillus paracasei LC19 supplementation

Intervention Type: DIETARY_SUPPLEMENT

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 probiotic milk powder

Group Type: PLACEBO_COMPARATOR

Placebo probiotic milk powder

Intervention Type: DIETARY_SUPPLEMENT

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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Chao Yang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guang Wang

Director of Endocrinology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guang Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Chao Yang Hospital

Locations

Beijing Chao-yang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jia Liu, MD

Role: CONTACT

liujia0116@126.com

010-85231710

Xiaoyu Ding, MD

Role: CONTACT

dxycy0828@163.com

010-85231711

Facility Contacts

Jia Liu, MD

Role: primary

dxycy0828@163.com

010-8523161710 ext. liujia0116@126

Other Identifiers

2024-DM-Lp

Identifier Type: -

Identifier Source: org_study_id