Type 1 DiabetesPhase 2NCT04141761
Probiotics in Newly Diagnosed T1D
A Phase 2 study testing Visbiome in people with Type 1 Diabetes and Type1diabetes, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The investigators aim to further the understanding of environmental factors that underlie the development of Type 1 diabetes (T1D) and the post-onset disease trajectory. Dysbiosis, defined as alterations in intestinal microbiota composition and function, has been hypothesized to increase the risk of developing T1D in… Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Type 1 Diabetes, Type1diabetes, Type 1 Diabetes Mellitus
- What is being tested?
- Visbiome
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Child
Who may be able to join
- Patients must meet all of the following criteria:
- Males and females 5-17 years of age with a clinical diagnosis of T1D within the past 90 days
- Positive for ≥ 1 diabetes-related autoantibodies (IAA, GAD, IA-2, or ZnT8)
- Stimulated C-peptide area under the curve (AUC) of ≥ 0.2 nmol/L during a mixed meal tolerance test
- Treatment naïve of any immunomodulatory agent
Who cannot join
- Patients must NOT meet any of the following criteria:
- Probiotic use within 1 month of screening visit
- Presence of severe, active disease that requires the use of chronic medication, with the exception of well-controlled autoimmune thyroiditis/hypothyroidism
- Diabetes other than T1D
- Female participants of child-bearing age with reproductive potential must not be knowingly pregnant
- Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Probiotic-induced Normalization of Innate Inflammation in Youth Newly Diagnosed With Type 1 Diabetes
The investigators aim to further the understanding of environmental factors that underlie the development of Type 1 diabetes (T1D) and the post-onset disease trajectory. 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, the investigators propose to examine the impact of dysbiosis on the endogenous innate inflammatory state that potentiates T1D progression. The investigators hypothesize that probiotic-induced alterations in the intestinal microbiota may favorably alter the post-onset disease state.
- Conditions
- Type 1 Diabetes, Type1diabetes, Type 1 Diabetes Mellitus
- Being tested
- Visbiome, Placebo
- Keywords
- Newly diagnosed, Recent onset, Visbiome, Probiotic
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VisbiomeDietary supplement
This group will receive Visbiome probiotic in powder form.
PlaceboOther
This group will receive a placebo in powder form.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Not described Receives: Dietary Supplement: Visbiome |
| Placebo Group | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Multistrain Probiotic on Immune System Inflammation as measured by plasma transcription analysis
Investigators will examine the effect of multistrain probiotic supplementation on the endogenous innate inflammatory state in youth newly diagnosed with T1D, as measured by plasma-induced transcription analysis. The investigators hypothesize that the participants receiving the probiotic will have less inflammation (as measured by transcriptional analysis) than the participants in the placebo group.
Measured: 3 years (duration of study)
Secondary outcomes (5)
C-peptide decline
Investigators will examine the effect of multistrain probiotic supplementation on the post-onset rate of C-peptide decline (a measure of beta cell health)
Measured: 3 years (duration of study)
Effect of Multistrain Probiotic on broader Immune System Effects as measured by plasma-induced transcriptional analyses
Investigators will examine the effect of multistrain probiotic supplementation on changes to the plasma-induced transcriptional assay to assess for probiotic-specific immune effects. Plasma-induced transcriptional analyses will be compared before and after treatment with probiotic/placebo. The investigators hypothesize that the participants receiving the probiotic will see reduced inflammation (as measured by transcriptional analysis) while those that received the placebo will see no change or increased inflammation.
Measured: 3 years (duration of study)
Cytokine Levels (a measure of inflammation) as measured by plasma analysis
Cytokine levels before and after treatment will be measured by plasma analysis. It is hypothesized that the levels of cytokines in the blood will be lower after treatment for the participants receiving the probiotic but not for those receiving the placebo.
Measured: 3 years (duration of study)
Changes to intestinal bacteria as measured by stool analysis
Investigators will examine the effect of multistrain probiotic supplementation the composition of the intestinal microbiota
Measured: 3 years (duration of study)
System-wide Effects as measured by systemic microbial antigen (a marker of intestinal permeability) as measured by plasma analysis
Gut leakiness will be measured by examining the levels of microbial antigens in the plasma before and after treatment and correlating these antigen levels with the changes in the composition of the gut bacteria. It is hypothesized that changes in antigen levels and gut bacteria will only be seen in the participants receiving the probiotic. It is further hypothesized that those with the greatest reduction in antigens will have the most significant changes in gut bacteria composition.
Measured: 3 years (duration of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start1 Apr 2019
- Primary completion30 Mar 2023
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind, placebo-controlled, 2:1 randomly assigned
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 43 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
- NCT04141761
- Sponsor's protocol ID
- 1343363
- Status last verified
- Oct 2025
- First submitted
- 23 Oct 2019
- Last updated
- 16 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotic-induced Normalization of Innate Inflammation in Youth Newly Diagnosed With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04141761
- Acronym / sponsor ID
- 1343363
- Conditions
- Type 1 Diabetes, Type1diabetes, Type 1 Diabetes Mellitus
- Keywords
- Newly diagnosed, Recent onset, Visbiome, Probiotic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 28 Oct 2019 (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.
The investigators aim to further the understanding of environmental factors that underlie the development of Type 1 diabetes (T1D) and the post-onset disease trajectory. 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, the investigators propose to examine the impact of dysbiosis on the endogenous innate inflammatory state that potentiates T1D progression. The investigators hypothesize that probiotic-induced alterations in the intestinal microbiota may favorably alter the post-onset disease state.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-blind, placebo-controlled, 2:1 randomly assigned
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Dietary Supplement: Visbiome |
| Placebo Group | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients must meet all of the following criteria:
Key exclusion criteria (6 listed)
- Patients must NOT meet any of the following criteria:
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 |
|---|---|---|
| VisbiomeThis group will receive Visbiome probiotic in powder form. | Dietary supplement | Treatment Group |
| PlaceboThis group will receive a placebo in powder form. | Other | Placebo Group |
Primary outcome
Effect of Multistrain Probiotic on Immune System Inflammation as measured by plasma transcription analysis
Time frame: 3 years (duration of study)
Investigators will examine the effect of multistrain probiotic supplementation on the endogenous innate inflammatory state in youth newly diagnosed with T1D, as measured by plasma-induced transcription analysis. The investigators hypothesize that the participants receiving the probiotic will have less inflammation (as measured by transcriptional analysis) than the participants in the placebo group.
5 secondary outcomes
C-peptide decline
Time frame: 3 years (duration of study)
Effect of Multistrain Probiotic on broader Immune System Effects as measured by plasma-induced transcriptional analyses
Time frame: 3 years (duration of study)
Cytokine Levels (a measure of inflammation) as measured by plasma analysis
Time frame: 3 years (duration of study)
Changes to intestinal bacteria as measured by stool analysis
Time frame: 3 years (duration of study)
System-wide Effects as measured by systemic microbial antigen (a marker of intestinal permeability) as measured by plasma analysis
Time frame: 3 years (duration of study)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- Individual participant dataSharing planned: No
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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 Phase 2 study testing Visbiome in people with Type 1 Diabetes and Type1diabetes, 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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Effect of Multistrain Probiotic on Immune System Inflammation as measured by plasma transcription analysis (time frame: 3 years (duration of study)). 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 16 Oct 2025.