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Modulation of Type 1 Diabetes Susceptibility Through the Use of Probiotics

Primary Purpose

Type1diabetes, Type1 Diabetes Mellitus

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

VSL#3

About this trial

This is an interventional other trial for Type1diabetes focused on measuring Siblings

Eligibility Criteria

5 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Medical College of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VSL#3

Arm Description

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.

Outcomes

Primary Outcome Measures

Alterations in Plasma-Induced Transcriptional Analysis

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

Secondary Outcome Measures

Intestinal Microbiota

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

Full Information

NCT ID

NCT03423589

First Posted

January 31, 2018

Last Updated

November 28, 2021

Sponsor

Medical College of Wisconsin

1. Study Identification

Unique Protocol Identification Number

NCT03423589

Brief Title

Modulation of Type 1 Diabetes Susceptibility Through the Use of Probiotics

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

April 23, 2018 (Actual)

Primary Completion Date

December 18, 2018 (Actual)

Study Completion Date

December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical College of Wisconsin

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type1diabetes, Type1 Diabetes Mellitus

Keywords

Siblings

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VSL#3

Arm Type

Experimental

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

VSL#3

Intervention Description

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 Measure Information:

Title

Alterations in Plasma-Induced Transcriptional Analysis

Description

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

Time Frame

2 years (study duration)

Secondary Outcome Measure Information:

Title

Intestinal Microbiota

Description

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

Time Frame

2 years (study duration)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Medical College of Wisconsin

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Modulation of Type 1 Diabetes Susceptibility Through the Use of Probiotics

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