Modulation of Type 1 Diabetes Susceptibility Through the Use of Probiotics

Type1diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03423589
• Other study ID #: 1171017
• Status: Completed
• Phase: N/A
• Start date: April 23, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: November 2021
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2018
• Est. primary completion date: December 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1 Diabetes Mellitus
• Type1diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alterations in Plasma-Induced Transcriptional Analysis	Examine the probiotic-induced alterations in the plasma-induced transcriptional analysis	2 years (study duration)
Secondary	Intestinal Microbiota	Examine the intestinal microbiota, plasma microbial antigen levels as a marker of gut barrier function	2 years (study duration)