Status:
ACTIVE_NOT_RECRUITING
Reducing Innate Inflammation in New Onset Type 1 Diabetes
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Type 1 Diabetes
type1diabetes
Eligibility:
All Genders
3-45 years
Phase:
PHASE2
Brief Summary
This study aims to determine whether Lactiplantibacillus plantarum 299v (Lp299v) supplementation will reduce systemic inflammation and prolong residual beta cell function in individuals newly diagnose...
Detailed Description
For individuals newly diagnosed with Type 1 diabetes, this clinical trial will assess whether probiotic supplementation has efficacy in reducing the endogenous systemic innate inflammatory state known...
Eligibility Criteria
Inclusion
- ≤ 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
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04335656
Start Date
April 1 2021
End Date
December 31 2026
Last Update
April 29 2025
Active Locations (1)
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1
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226