Can a probiotic help tame New-Onset diabetes?
NCT ID NCT07520305
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether a probiotic called Lactobacillus paracasei LC19 can help control blood sugar in people recently diagnosed with type 2 diabetes. About 70 adults who have not taken diabetes medication will take the probiotic daily for 12 weeks. Researchers will measure changes in blood sugar and other health markers to see if the probiotic works differently for different people.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Chao-yang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020, China
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Other studies related to the condition(s) this trial covers.
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