Type 2 DiabetesNCT06639425
Efficacy of Lactobacillus Paracasei LC19 on Type 2 Diabetes
A study testing Lactobacillus paracasei LC19 supplementation in people with Type 2 Diabetes, run by Beijing Chao Yang Hospital at 1 site in China.
Trial 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). 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 supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 12 Oct 2024to 3 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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.
China1 site
Beijing Chao-yang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020
About this study
Official title: Efficacy of Lactobacillus Paracasei LC19 on Newly Diagnosed Type 2 Diabetes
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).
Read the 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
- Being tested
- Lactobacillus paracasei LC19 supplementation, Placebo probiotic milk powder
- 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 supplementationDietary 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 powderDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus paracasei LC19 supplementation | Experimental | Not described Receives: Dietary Supplement: Lactobacillus paracasei LC19 supplementation |
| Placebo probiotic milk powder | Placebo comparator | Not described Receives: Dietary Supplement: Placebo probiotic milk powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c change
Changes in HbA1c from baseline at12 weeks during follow-up
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (9)
fasting blood glucose change
Changes in fasting blood glucose from baseline at 4, 8, and 12 weeks during follow-up
Measured: From baseline at 4, 8, and 12 weeks during follow-up
Glycated albumin change
Changes in glycated albumin from baseline at 4 and 12 weeks during follow-up
Measured: From baseline at 4 and 12 weeks during follow-up
Glycemic achieving rate
Glycemic achieving rate with HbA1c\<6.5% at 12-week follow-up
Measured: From enrollment to the end of treatment at 12 weeks
Glucose tolerance
Changes in blood glucose levels (at 0, 30, 60, and 120 minutes during OGTT) from baseline at 4 and 12 weeks during follow-up
Measured: From baseline at 4 and 12 weeks during follow-up
Insulin change
Changes in insulin levels (at 0, 30, 60, and 120 minutes during OGTT) from baseline at 4 and 12 weeks during follow-up
Measured: From baseline at 4 and 12 weeks during follow-up
Plasma GLP-1 change
Changes in GLP-1 levels (at 0, 30, 60, and 120 minutes during OGTT) from baseline at 4 and 12 weeks during follow-up
Measured: From baseline at 4 and 12 weeks during follow-up
BMI change
Changes in BMI from baseline at 4, 8, and 12 weeks during follow-up
Measured: From baseline at 4, 8, and 12 weeks during follow-up
Alteration of fecal metabolites
Fecal metabolites analysis from baseline to 12-week follow-up
Measured: From enrollment to the end of treatment at 12 weeks
Alteration of gut microbiome
Fecal metagenomics sequencing from baseline to 12-week follow-up
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start12 Oct 2024
- Primary completion3 Sep 2025
- Study completion3 Sep 2025
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
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, MD, Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639425
- Sponsor's protocol ID
- 2024-DM-Lp
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lactobacillus Paracasei LC19 on Newly Diagnosed Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06639425
- Acronym / sponsor ID
- 2024-DM-Lp
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 12 Oct 2024 (actual)
- Primary completion
- 3 Sep 2025 (actual)
- Study completion
- 3 Sep 2025 (actual)
- First posted
- 15 Oct 2024 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus paracasei LC19 supplementation | Experimental | Dietary Supplement: Lactobacillus paracasei LC19 supplementation |
| Placebo probiotic milk powder | Placebo comparator | Dietary Supplement: Placebo probiotic milk powder |
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\&amp;amp;#39;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 supplementationOrally 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). | Dietary supplement | Lactobacillus paracasei LC19 supplementation |
| Placebo probiotic milk powderOrally 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). | Dietary supplement | Placebo probiotic milk powder |
Primary outcome
HbA1c change
Time frame: From enrollment to the end of treatment at 12 weeks
Changes in HbA1c from baseline at12 weeks during follow-up
9 secondary outcomes
fasting blood glucose change
Time frame: From baseline at 4, 8, and 12 weeks during follow-up
Glycated albumin change
Time frame: From baseline at 4 and 12 weeks during follow-up
Glycemic achieving rate
Time frame: From enrollment to the end of treatment at 12 weeks
Glucose tolerance
Time frame: From baseline at 4 and 12 weeks during follow-up
Insulin change
Time frame: From baseline at 4 and 12 weeks during follow-up
Plasma GLP-1 change
Time frame: From baseline at 4 and 12 weeks during follow-up
BMI change
Time frame: From baseline at 4, 8, and 12 weeks during follow-up
Alteration of fecal metabolites
Time frame: From enrollment to the end of treatment at 12 weeks
Alteration of gut microbiome
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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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. This study is not recruiting at the moment.
Guang Wang, MD 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 supplementation 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: finished, as of the sponsor's last update on 13 Oct 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c change (time frame: From enrollment to the end of treatment at 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 13 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.