NCT04335656

Reducing Innate Inflammation in New Onset Type 1 Diabetes

Reducing Innate Inflammation in New Onset Type 1 Diabetes With Lactiplantibacillus Plantarum

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 3 Years – 45 Years
• Healthy volunteers: Not accepted

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 diagnosed with Type 1 diabetes. The investigators hypothesize that probiotic-induced alterations in the intestinal microbiota may favorably alter the post-onset disease state.

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 to exist in newly diagnosed Type 1 diabetes and whether this reduction correlates with preservation of endogenous insulin production as measured by stimulated C-peptide during mixed meal tolerance testing (MMTT). The innate inflammatory state will be measured by plasma-induced transcriptional assay and quantified as a composite inflammatory index. Mixed meal tolerance testing is the gold standard measure of endogenous insulin production. During this test, serial blood c-peptide levels are collected over 2 hours in response to challenge with a nutritional drink containing a mix of protein, fat, and carbohydrate and the C-peptide area under the curve is calculated. Using a randomized, placebo-controlled design, the investigators will measure changes in systemic inflammation (primary outcome) and beta cell function (secondary outcome) after six months of daily treatment with either Lp299v supplementation or placebo. These measures of plasma-induced transcriptional assay and MMTT will be related to markers of beta cell stress, the composition of the gut microbiota, analysis of the plasma metabolome, and levels of microbial antigen exposure.

Conditions

• Type 1 Diabetes
• type1diabetes
• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactiplantibacillus plantarum	Probiotic capsule in powder form, which can be swallowed or opened and contents sprinkled on cold foods or beverages
OTHER	Placebo	Placebo capsule in powder form, which can be swallowed or opened and contents sprinkled on cold foods or beverages

Timeline

• Start date: 2021-04-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2020-04-06
• Last updated: 2026-03-16

Locations

1 site across 1 country: United States