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Modulation of Type 1 Diabetes Susceptibility Through the Use of Probiotics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03423589
Recruitment Status : Completed
First Posted : February 6, 2018
Last Update Posted : October 25, 2019
Information provided by (Responsible Party):
Susanne Cabrera, Medical College of Wisconsin

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.

Condition or disease Intervention/treatment Phase
Type1diabetes Type1 Diabetes Mellitus Dietary Supplement: VSL#3 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Modulation of Type 1 Diabetes Susceptibility Through VSL#3 Probiotic-induced Alterations in the Intestinal Microbiota
Actual Study Start Date : April 23, 2018
Actual Primary Completion Date : December 18, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: VSL#3
Participants will be given the probiotic supplement VSL#3, a commercially available product. VSL#3 is taken by mouth, either once or twice daily, and is dispensed in sachets, each containing 450 billion colony forming units of bacterial strains. Participants will undergo a screening visit. They will be asked to provide a stool sample by the next visit. Within 3 weeks they will return with a stool sample and receive the VSL#3 sachets as well as another stool collection kit. After 6 weeks of taking VSL#3, they will return for their final visit, with their stool sample. Blood will be drawn at the second and third visits.
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.

Primary Outcome Measures :
  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 Outcome Measures :
  1. Intestinal Microbiota [ Time Frame: 2 years (study duration) ]
    Examine the intestinal microbiota, plasma microbial antigen levels as a marker of gut barrier function

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03423589

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United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
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Responsible Party: Susanne Cabrera, MD, Medical College of Wisconsin Identifier: NCT03423589    
Other Study ID Numbers: 1171017
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Susanne Cabrera, Medical College of Wisconsin:
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases