Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06639425

Efficacy of Lactobacillus Paracasei LC19 on Type 2 Diabetes

Led by Beijing Chao Yang Hospital · Updated on 2025-02-07

60

Participants Needed

1

Research Sites

115 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Efficacy of Lactobacillus Paracasei LC19 on Type 2 Diabetes

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-65 years, both genders eligible
  • Drug-naive patients with newly diagnosed type 2 diabetes
  • Subjects with screening HbA1c 27 7.0% and 27 9.0%
  • Subjects understand the nature, significance, potential benefits, inconvenience, and risks and procedure of the study, and voluntarily sign the informed consent form
Not Eligible

You will not qualify if you...

  • 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)
  • 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 27 III or serious cardiovascular diseases within 6 months before screening
  • 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 affecting digestion and absorption or recent gastrointestinal surgery within one year before screening
  • Subjects with history of surgery or severe trauma in the past 6 months or planning surgery during the study
  • Subjects suffering from severe infections, severe anemia, or neutropenia
  • Subjects pregnant or in lactation, or planning pregnancy during or within 3 months after the study
  • Subjects with history of receiving immunosuppressants, steroids, anti-diarrheal drugs, antibiotics, lipid-lowering drugs, or gastrointestinal motility medications within past 3 months
  • Subjects using other medications affecting blood glucose in the past 3 months
  • Subjects consuming other probiotic or prebiotic products in the past 3 months before screening
  • Subjects with lactose intolerance, known or suspected allergy to probiotics used, or history of drug allergies/allergic diseases
  • Subjects with weight fluctuations 27 5kg in past 3 months or planning weight control medication during study
  • Subjects with history of mental illness or epilepsy, or taking antidepressants
  • Subjects with history of alcohol abuse (men exceeding 40g/day, women exceeding 20g/day)
  • Subjects who participated in any other clinical study in the past 3 months

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Beijing Chao-yang Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100020

Actively Recruiting

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Research Team

J

Jia Liu, MD

CONTACT

X

Xiaoyu Ding, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Efficacy of Lactobacillus Paracasei LC19 on Type 2 Diabetes | DecenTrialz