Reducing Innate Inflammation in New Onset Type 1 Diabetes

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Type 1 Diabetes, type1diabetes, Type 1 Diabetes Mellitus

In brief

This study aims to determine whether Lactiplantibacillus plantarum 299v (Lp299v) supplementation will reduce systemic inflammation and prolong residual beta cell function in individuals newly diagnosed with Type 1 diabetes. The investigators hypothesize that probiotic-induced alterations in the intestinal microbiota may favorably alter the post-onset disease state.

Key facts

Study ID

NCT04335656

Run by

Medical College of Wisconsin

People needed

60

Starts

2021-04-01

Expected to finish

2027-12-31

Last updated by the study team

2026-03-16

Who can join

Age: 3 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≤ 100 days from T1D diagnosis based on ADA criteria
• > 21 days from T1D diagnosis or metabolically stable per study physician assessment
• Males and females 3-45 years of age, inclusive, at time of screening visit
• Peak MMTT stimulated C-peptide ≥ 0.2 nmol/L
• Positive for at least 1 diabetes autoantibody (excluding mIAA in those who have received ≥ 2 weeks of exogenous insulin therapy) either through clinically obtained labs at time of diagnosis or as obtained at the screening visit
• Females of child-bearing potential (defined as any female who has reached menarche (first menses), excluding those who have had a hysterectomy or are post-menopausal and must be willing to use effective birth control (which may include abstinence)) from screening visit until final study visit
• Willing and able to give informed consent or have parent or legal guardian provide informed consent if the subject is < 18 years of age

You may not qualify if…

• Probiotic supplement use within the past month
• Antibiotic use within the past month
• Concurrent or recent (within the past 30 days of screening) use of non-insulin therapies aimed to control hyperglycemia
• Females who are pregnant or lactating
• Chronic inflammatory or autoimmune disease with exception of stable thyroid disease
• Uncontrolled celiac disease (i.e., consuming gluten) or actively being evaluated for possible celiac disease (i.e., clinically obtained tissue transglutaminase IgA titers above reference range, being referred to gastroenterology for possible endoscopy, etc.)
• Use of glucocorticoids or other immunosuppressive agents within 30 days of screening MMTT
• Use of medications known to influence glucose tolerance
• Dairy allergy
• Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results.

Where it is running

• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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