Type1diabetesNCT03423589
Modulation of Type 1 Diabetes Susceptibility Through the Use of Probiotics
A study testing VSL#3 in people with Type1diabetes and Type1 Diabetes Mellitus, run by Medical College of Wisconsin at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Type1diabetes, Type1 Diabetes Mellitus
- What is being tested?
- VSL#3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2018to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: 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.
- Conditions
- Type1diabetes, Type1 Diabetes Mellitus
- Being tested
- VSL#3
- Keywords
- Siblings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VSL#3Dietary 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.
| Study group | Role | What they receive |
|---|---|---|
| VSL#3 | Experimental | 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. Receives: Dietary Supplement: VSL#3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alterations in Plasma-Induced Transcriptional Analysis
Examine the probiotic-induced alterations in the plasma-induced transcriptional analysis
Measured: 2 years (study duration)
Secondary outcomes (1)
Intestinal Microbiota
Examine the intestinal microbiota, plasma microbial antigen levels as a marker of gut barrier function
Measured: 2 years (study duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start23 Apr 2018
- Primary completion18 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susanne Cabrera, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423589
- Sponsor's protocol ID
- 1171017
- Status last verified
- Jul 2024
- First submitted
- 31 Jan 2018
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Type 1 Diabetes Susceptibility Through VSL#3 Probiotic-induced Alterations in the Intestinal Microbiota
- ClinicalTrials.gov ID
- NCT03423589
- Acronym / sponsor ID
- 1171017
- Conditions
- Type1diabetes, Type1 Diabetes Mellitus
- Keywords
- Siblings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 18 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 6 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VSL#3 | Experimental | Dietary Supplement: VSL#3Participants 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. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VSL#3VSL#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. | Dietary supplement | VSL#3 |
Primary outcome
Alterations in Plasma-Induced Transcriptional Analysis
Time frame: 2 years (study duration)
Examine the probiotic-induced alterations in the plasma-induced transcriptional analysis
1 secondary outcome
Intestinal Microbiota
Time frame: 2 years (study duration)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VSL#3 in people with Type1diabetes and Type1 Diabetes Mellitus, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alterations in Plasma-Induced Transcriptional Analysis (time frame: 2 years (study duration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.