Reducing Innate Inflammation in New Onset Type 1 Diabetes

StatusActive, Not Recruiting
PhasePhase 2
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Final enrollment: 51 participants (planned 60)
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 3 of 7 entries
  2. Primary completion date: May 31, 2026 to Dec 31, 2026
    • Study completion date: Dec 31, 2026 to Dec 31, 2027
    v12
  3. Primary completion date: May 31, 2025 to May 31, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v11
  4. Re-verified, no change to tracked fieldsv10
  5. Study completion date: May 31, 2025 to Dec 31, 2026v9
Show 7 earlier versionsHide 7 earlier versions
  1. Re-verified, no change to tracked fieldsv8
  2. Primary completion date: Dec 31, 2024 to May 31, 2025
    • Study completion date: Dec 31, 2026 to May 31, 2025
    v7
  3. Interventions: Lactobacillus plantarum (Dietary Supplement), Placebo (Other) to Lactiplantibacillus plantarum (Dietary Supplement), Placebo (Other)
    • Eligibility criteria expanded, about 2 words
    v6
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 1, 2021 to Apr 1, 2021
    • Site details revised
    v5
  5. Start date: Jan 1, 2021 to Mar 1, 2021v4
  6. Start date: Oct 1, 2020 to Jan 1, 2021v3
  7. Start date: May 1, 2020 to Oct 1, 2020v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04335656
Lead Sponsor Medical College of Wisconsin
Conditions
(from sponsor)		 Type 1 Diabetes, type1diabetes, Type 1 Diabetes Mellitus
Related terms Diabetes Mellitus, Type 1
Enrollment 51 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov