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Modulation of Type 1 Diabetes Susceptibility Through the Use of Probiotics

NCT03423589 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-07-22

No results posted yet for this study

Summary

Investigators aim to further the understanding of environmental factors that underlie the progression to Type 1 diabetes (T1D). 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, investigators propose to examine the impact of dysbiosis on the endogenous innate inflammation known to exist within families affected by T1D and if probiotic supplementation may beneficially modulate this inflammatory state.

Participants will be asked to take the probiotic VSL#3 daily for six weeks. Stool and blood samples will be analyzed before and after the six week course of probiotics.

Conditions

  • Type1diabetes
  • Type1 Diabetes Mellitus

Interventions

DIETARY_SUPPLEMENT

VSL#3

VSL#3 is a commercially available probiotic supplement manufactured and distributed by Alfasigma USA, Inc of Covington, Louisiana, USA. As with other probiotics, VSL#3 is considered a supplement and is not FDA-approved or regulated. VSL#3 contains eight probiotic strains: bifidobacteria (B. longum, B. infantis, and B. breve), lactobacilli (L. acidophilus, L. casei, L. bulgaricus, and L. plantarum) and Strepococcus thermophiles.

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-23
Primary Completion
2018-12-18
Completion
2018-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03423589 on ClinicalTrials.gov