NCT03423589

Modulation of Type 1 Diabetes Susceptibility Through the Use of Probiotics

Modulation of Type 1 Diabetes Susceptibility Through VSL#3 Probiotic-induced Alterations in the Intestinal Microbiota

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2018-04-23
• Primary completion: 2018-12-18
• Completion: 2018-12-31
• First posted: 2018-02-06
• Last updated: 2024-07-22

Locations

1 site across 1 country: United States