Modulation of Type 1 Diabetes Susceptibility Through the Use of Probiotics
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 5 - 17 |
| Updated: | 3/8/2019 |
| Start Date: | April 23, 2018 |
| End Date: | December 31, 2018 |
Modulation of Type 1 Diabetes Susceptibility Through VSL#3 Probiotic-induced Alterations in the Intestinal Microbiota
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.
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.
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
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