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Completed

NCT Number: NCT03423589

Modulation of Type 1 Diabetes Susceptibility Through the Use of Probiotics

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.

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Key information

Conditions

Type1diabetes Type1 Diabetes Mellitus

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females 5-17 years of age
  • Full-sibling of an individual with a clinical diagnosis of Type 1 diabetes
  • Treatment naïve of any immunomodulatory agent
  • Naïve of any probiotic supplement within the past 12 months

Exclusion criteria

  • Presence of severe/active disease that interferes with dietary intake
  • Chronic use of medications known to affect gastrointestinal function, such as stool softeners or laxatives
  • Diagnosis of celiac disease and/or following a gluten-free diet
  • Presence of significant and sustained gastrointestinal symptoms within the prior 6 weeks (e.g., severe abdominal pain, worsening constipation, diarrhea, or recurrent nausea +/- vomiting)
  • 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
  • Use of any medications that could affect intestinal microbiota within the previous 3 months (e.g., antibiotics, prebiotics, or probiotics)
  • Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results
  • Female participants of child-bearing age must not be pregnant

Treatment and study plan

VSL#3

Dietary Supplement

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.

Primary outcomes

  1. Alterations in Plasma-Induced Transcriptional Analysis

    Time frame: 2 years (study duration)

    Examine the probiotic-induced alterations in the plasma-induced transcriptional analysis

Secondary outcomes

  1. Intestinal Microbiota

    Time frame: 2 years (study duration)

    Examine the intestinal microbiota, plasma microbial antigen levels as a marker of gut barrier function

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 6, 2018
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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