A Study of the Efficacy Heterogeneity of Lactobacillus Paracasei LC19 Intervention in Patients With Newly Diagnosed Type 2 Diabetes
New trial explores probiotic for newly diagnosed Type 2 Diabetes
Plain English Summary
Efficacy Heterogeneity of Lactobacillus Paracasei LC19 on Type 2 Diabetes is a Not Applicable clinical trial sponsored by Beijing Chao Yang Hospital studying Type 2 Diabetes. This study tests if a specific probiotic, Lactobacillus paracasei LC19, can help manage blood sugar in people newly diagnosed with Type 2 Diabetes. It is for adults aged 18-65 who have recently been diagnosed with Type 2 Diabetes and are not currently on diabetes medication. Participants will take the probiotic daily for 12 weeks, and their blood sugar levels will be monitored. Currently, standard treatment for newly diagnosed Type 2 Diabetes involves lifestyle changes and often medication; this study explores a potential dietary supplement as an additional option. The trial aims to enroll 70 participants.
Official Summary
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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are between 18 and 65 years old, have been newly diagnosed with Type 2 Diabetes, and your average blood sugar (HbA1c) is between 7.0% and 9.0%. You cannot join if you have other types of diabetes (like Type 1), have had recent serious heart problems, have severe liver or kidney issues, or have a history of certain gastrointestinal diseases. Pregnant or breastfeeding individuals, or those planning to become pregnant, cannot participate. You also cannot join if you have recently used certain medications like antibiotics, steroids, or other probiotics, or if you have a history of cancer or severe infections. This trial is studying Type 2 Diabetes, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how much the probiotic changes your HbA1c, which is a key indicator of your average blood sugar control over the past 2-3 months. The specific primary outcome measures are: HbA1c change (12 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it investigates a potential new approach using a probiotic to help manage blood sugar in newly diagnosed Type 2 Diabetes, addressing a need for diverse treatment options. This research targets Type 2 Diabetes, where improved treatment options are needed.
Investor Insight
This trial focuses on a specific probiotic for a large and growing market of Type 2 Diabetes patients, with potential for a novel dietary supplement if proven effective.
Is This Trial Right for Me?
Ask your doctor if this probiotic is appropriate for you, especially considering your current health and any other medications you take. Participation involves taking the probiotic daily for 12 weeks and attending regular check-ups to monitor your blood sugar and overall health. You will need to avoid other probiotic or prebiotic supplements during the study. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 70 participants
Interventions
- DIETARY_SUPPLEMENT: Lactobacillus paracasei LC19 Intervention — All participants will receive oral Lactobacillus paracasei LC19 powder (2 g/packet, 2 packets/day) for 12 weeks.
Primary Outcomes
- HbA1c change (12 weeks)
Secondary Outcomes
- Glucose tolerance (12 weeks)
- Plasma GLP-1 change (12 weeks)
- BMI change (12 weeks)
- Weight change (12 weeks)
- Alteration of gut microbiome (12 weeks)
Full 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
Trial Locations
- Beijing Chao-yang Hospital, Capital Medical University, Beijing, Beijing Municipality, China
Frequently Asked Questions
What is clinical trial NCT07520305?
NCT07520305 is a Not Applicable INTERVENTIONAL study titled "Efficacy Heterogeneity of Lactobacillus Paracasei LC19 on Type 2 Diabetes." It is currently not yet recruiting and is sponsored by Beijing Chao Yang Hospital. The trial targets enrollment of 70 participants.
What conditions does NCT07520305 study?
This trial investigates treatments for Type 2 Diabetes. The primary condition under study is Type 2 Diabetes.
What treatments are being tested in NCT07520305?
The interventions being studied include: Lactobacillus paracasei LC19 Intervention (DIETARY_SUPPLEMENT). All participants will receive oral Lactobacillus paracasei LC19 powder (2 g/packet, 2 packets/day) for 12 weeks.
What does Not Applicable mean for NCT07520305?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07520305?
This trial is currently "Not Yet Recruiting." It started on 2026-04-20. The estimated completion date is 2028-03-31.
Who is sponsoring NCT07520305?
NCT07520305 is sponsored by Beijing Chao Yang Hospital. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07520305?
The trial aims to enroll 70 participants. The trial has not yet started recruiting.
How is NCT07520305 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT07520305?
The primary outcome measures are: HbA1c change (12 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07520305 being conducted?
This trial is being conducted at 1 site, including Beijing, Beijing Municipality (China).
Where can I find official information about NCT07520305?
The official record for NCT07520305 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07520305. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07520305 testing in simple terms?
This study tests if a specific probiotic, Lactobacillus paracasei LC19, can help manage blood sugar in people newly diagnosed with Type 2 Diabetes. It is for adults aged 18-65 who have recently been diagnosed with Type 2 Diabetes and are not currently on diabetes medication.
Why is this trial significant?
This trial matters because it investigates a potential new approach using a probiotic to help manage blood sugar in newly diagnosed Type 2 Diabetes, addressing a need for diverse treatment options.
What are the potential risks of participating in NCT07520305?
The most common risks associated with probiotics are mild digestive issues like gas or bloating. There is a small risk of allergic reaction to the probiotic ingredients. As this is a single-group study, it's important to note that the observed changes are attributed to the probiotic, but direct comparison to a placebo is not part of this specific design. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07520305?
Ask your doctor if this probiotic is appropriate for you, especially considering your current health and any other medications you take. Participation involves taking the probiotic daily for 12 weeks and attending regular check-ups to monitor your blood sugar and overall health. You will need to avoid other probiotic or prebiotic supplements during the study. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07520305 signal from an investment perspective?
This trial focuses on a specific probiotic for a large and growing market of Type 2 Diabetes patients, with potential for a novel dietary supplement if proven effective. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will take the probiotic daily for 12 weeks, and their blood sugar levels will be monitored. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.