Type1diabetes, Type1 Diabetes Mellitus
Conditions
Keywords
Siblings
Brief 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.
Interventions
DIETARY_SUPPLEMENTVSL#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
Medical College of Wisconsin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males and females 5-17 years of age 2. Full-sibling of an individual with a clinical diagnosis of Type 1 diabetes 3. Treatment naïve of any immunomodulatory agent 4. Naïve of any probiotic supplement within the past 12 months
Exclusion criteria
1. Presence of severe/active disease that interferes with dietary intake 2. Chronic use of medications known to affect gastrointestinal function, such as stool softeners or laxatives 3. Diagnosis of celiac disease and/or following a gluten-free diet 4. Presence of significant and sustained gastrointestinal symptoms within the prior 6 weeks (e.g., severe abdominal pain, worsening constipation, diarrhea, or recurrent nausea +/- vomiting) 5. Chronic inflammatory or autoimmune disease with the exception of well-controlled hypothyroidism or intermittent or mild persistent asthma not requiring the use of daily inhaled steroids 6. Use of any medications that could affect intestinal microbiota within the previous 3 months (e.g., antibiotics, prebiotics, or probiotics) 7. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results 8. Female participants of child-bearing age must not be pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alterations in Plasma-Induced Transcriptional Analysis | 2 years (study duration) | Examine the probiotic-induced alterations in the plasma-induced transcriptional analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intestinal Microbiota | 2 years (study duration) | Examine the intestinal microbiota, plasma microbial antigen levels as a marker of gut barrier function |
Countries
United States
Outcome results
None listed