Type 2 DiabetesNCT07520305
Efficacy Heterogeneity of Lactobacillus Paracasei LC19 on Type 2 Diabetes
A study testing Lactobacillus paracasei LC19 Intervention in people with Type 2 Diabetes, run by Beijing Chao Yang Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Lactobacillus paracasei LC19 Intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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 and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Chao-yang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020
Xiaoyu Ding, 010-85231711, dxycy0828@163.com
About this study
Official title: A Study of the Efficacy Heterogeneity of Lactobacillus Paracasei LC19 Intervention in Patients With Newly Diagnosed Type 2 Diabetes
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.
Read the detailed description
This is a single-center, open-label, single-arm study designed to investigate inter-individual variability in glycemic response to Lactobacillus paracasei LC19 (LC19) in patients with newly diagnosed type 2 diabetes (T2D). A total of 70 eligible participants with newly diagnosed T2DM will be enrolled. All participants will receive oral LC19 strain powder (2 packets per day, 2 g per packet) for 12 weeks. No placebo or active comparator will be included in this study.
- Conditions
- Type 2 Diabetes
- Being tested
- Lactobacillus paracasei LC19 Intervention
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus paracasei LC19 InterventionDietary supplement
All participants will receive oral Lactobacillus paracasei LC19 powder (2 g/packet, 2 packets/day) for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus paracasei LC19 supplementation | Experimental | All participants will receive oral Lactobacillus paracasei LC19 powder (2g/packet, 2 packets/day) for 12 weeks. Receives: Dietary Supplement: Lactobacillus paracasei LC19 Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c change
Changes in HbA1c from baseline to week 12 during follow-up
Measured: 12 weeks
Secondary outcomes (5)
Glucose tolerance
Changes in blood glucose levels during OGTT (at 0, 30, 60, 120 min) from baseline to week 4 and week 12
Measured: 12 weeks
Plasma GLP-1 change
Changes in GLP-1 levels during OGTT (at 0, 30, 60, 120 min) from baseline to week 4 and week 12
Measured: 12 weeks
BMI change
Change in BMI from baseline to week 4, week 8, and week 12
Measured: 12 weeks
Weight change
Change in weight from baseline to week 4, week 8, and week 12
Measured: 12 weeks
Alteration of gut microbiome
Fecal metagenomics sequencing from baseline to 12-week follow-up
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guang Wang, Beijing Chao Yang Hospital
- Investigators
- Guang Wang, Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520305
- Sponsor's protocol ID
- 2026-DM-Lp
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Efficacy Heterogeneity of Lactobacillus Paracasei LC19 Intervention in Patients With Newly Diagnosed Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07520305
- Acronym / sponsor ID
- 2026-DM-Lp
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single-center, open-label, single-arm study designed to investigate inter-individual variability in glycemic response to Lactobacillus paracasei LC19 (LC19) in patients with newly diagnosed type 2 diabetes (T2D). A total of 70 eligible participants with newly diagnosed T2DM will be enrolled. All participants will receive oral LC19 strain powder (2 packets per day, 2 g per packet) for 12 weeks. No placebo or active comparator will be included in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus paracasei LC19 supplementation | Experimental | Dietary Supplement: Lactobacillus paracasei LC19 InterventionAll participants will receive oral Lactobacillus paracasei LC19 powder (2g/packet, 2 packets/day) for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus paracasei LC19 InterventionAll participants will receive oral Lactobacillus paracasei LC19 powder (2 g/packet, 2 packets/day) for 12 weeks. | Dietary supplement | Lactobacillus paracasei LC19 supplementation |
Primary outcome
HbA1c change
Time frame: 12 weeks
Changes in HbA1c from baseline to week 12 during follow-up
5 secondary outcomes
Glucose tolerance
Time frame: 12 weeks
Plasma GLP-1 change
Time frame: 12 weeks
BMI change
Time frame: 12 weeks
Weight change
Time frame: 12 weeks
Alteration of gut microbiome
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guang Wang principal investigator
Beijing Chao Yang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus paracasei LC19 Intervention in people with Type 2 Diabetes, run by Beijing Chao Yang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jia Liu (010-85231710, liujia0116@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c change (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.