Actively Recruiting
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
Eligibility Criteria
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
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
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Chao-yang Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100020
Actively Recruiting
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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