Clinical trial NCT04141761: Probiotics in Newly Diagnosed T1D
Official title: Probiotic-induced Normalization of Innate Inflammation in Youth Newly Diagnosed with Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Type 1 Diabetes
Type1diabetes
Type 1 Diabetes Mellitus
Keywords: Newly diagnosed
Recent onset
Visbiome
Probiotic
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2019-10-28
Enrollment: 43
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind, placebo-controlled, 2:1 randomly assigned
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Effect of Multistrain Probiotic on Immune System Inflammation as measured by plasma transcription analysis
timeFrame: 3 years (duration of study)
Secondary outcomes:
measure: C-peptide decline
timeFrame: 3 years (duration of study)
measure: Effect of Multistrain Probiotic on broader Immune System Effects as measured by plasma-induced transcriptional analyses
timeFrame: 3 years (duration of study)
measure: Cytokine Levels (a measure of inflammation) as measured by plasma analysis
timeFrame: 3 years (duration of study)
measure: Changes to intestinal bacteria as measured by stool analysis
timeFrame: 3 years (duration of study)
measure: System-wide Effects as measured by systemic microbial antigen (a marker of intestinal permeability) as measured by plasma analysis
timeFrame: 3 years (duration of study)
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: