Probiotics in Newly Diagnosed T1D

Phase 2Active Not RecruitingNCT04141761

Medical College of Wisconsin43 enrolled

Overview

The investigators aim to further the understanding of environmental factors that underlie the development of Type 1 diabetes (T1D) and the post-onset disease trajectory. Dysbiosis, defined as alterations in intestinal microbiota composition and function, has been hypothesized to increase the risk of developing T1D in those with genetic susceptibility. Dysbiosis may result from modern dietary habits, such as broad consumption of the highly processed Western Diet, or by widespread use of antibiotics. Here, the investigators propose to examine the impact of dysbiosis on the endogenous innate inflammatory state that potentiates T1D progression. The investigators hypothesize that probiotic-induced alterations in the intestinal microbiota may favorably alter the post-onset disease state.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Type 1 Diabetes Type1diabetes Type 1 Diabetes Mellitus

Eligibility

Sex: ALLMin age: 5 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients must meet all of the following criteria: 1. Males and females 5-17 years of age with a clinical diagnosis of T1D within the past 90 days 2. Positive for ≥ 1 diabetes-related autoantibodies (IAA, GAD, IA-2, or ZnT8) 3. Stimulated C-peptide area under the curve (AUC) of ≥ 0.2 nmol/L during a mixed meal tolerance test 4. Treatment naïve of any immunomodulatory agent Exclusion Criteria: * Patients must NOT meet any of the following criteria: 1. Probiotic use within 1 month of screening visit 2. Presence of severe, active disease that requires the use of chronic medication, with the exception of well-controlled autoimmune thyroiditis/hypothyroidism 3. Diabetes other than T1D 4. Female participants of child-bearing age with reproductive potential must not be knowingly pregnant 5. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results

Outcomes

Primary Outcomes

Effect of Multistrain Probiotic on Immune System Inflammation as measured by plasma transcription analysis

Investigators will examine the effect of multistrain probiotic supplementation on the endogenous innate inflammatory state in youth newly diagnosed with T1D, as measured by plasma-induced transcription analysis. The investigators hypothesize that the participants receiving the probiotic will have less inflammation (as measured by transcriptional analysis) than the participants in the placebo group.