Type 1 DiabetesPhase 2NCT04335656
Reducing Innate Inflammation in New Onset Type 1 Diabetes
A Phase 2 study testing Lactiplantibacillus plantarum in people with Type 1 Diabetes and type1diabetes, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This study aims to determine whether Lactiplantibacillus plantarum 299v (Lp299v) supplementation will reduce systemic inflammation and prolong residual beta cell function in individuals newly diagnosed with Type 1 diabetes. Read more about this study
- Who is it for?
- Ages 3 to 45 years
- Conditions the study is for
- Type 1 Diabetes, type1diabetes, Type 1 Diabetes Mellitus
- What is being tested?
- Lactiplantibacillus plantarum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 31 Dec 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 3 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ≤ 100 days from T1D diagnosis based on ADA criteria
- > 21 days from T1D diagnosis or metabolically stable per study physician assessment
- Males and females 3-45 years of age, inclusive, at time of screening visit
- Peak MMTT stimulated C-peptide ≥ 0.2 nmol/L
- Positive for at least 1 diabetes autoantibody (excluding mIAA in those who have received ≥ 2 weeks of exogenous insulin therapy) either through clinically obtained labs at time of diagnosis or as obtained at the screening visit
- Females of child-bearing potential (defined as any female who has reached menarche (first menses), excluding those who have had a hysterectomy or are post-menopausal and must be willing to use effective birth control (which may include abstinence)) from screening visit until final study visit
- Willing and able to give informed consent or have parent or legal guardian provide informed consent if the subject is < 18 years of age
Who cannot join
- Probiotic supplement use within the past month
- Antibiotic use within the past month
- Concurrent or recent (within the past 30 days of screening) use of non-insulin therapies aimed to control hyperglycemia
- Females who are pregnant or lactating
- Chronic inflammatory or autoimmune disease with exception of stable thyroid disease
- Uncontrolled celiac disease (i.e., consuming gluten) or actively being evaluated for possible celiac disease (i.e., clinically obtained tissue transglutaminase IgA titers above reference range, being referred to gastroenterology for possible endoscopy, etc.)
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- Use of glucocorticoids or other immunosuppressive agents within 30 days of screening MMTT
- Use of medications known to influence glucose tolerance
- Dairy allergy
- 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: Reducing Innate Inflammation in New Onset Type 1 Diabetes With Lactiplantibacillus Plantarum
This study aims to determine whether Lactiplantibacillus plantarum 299v (Lp299v) supplementation will reduce systemic inflammation and prolong residual beta cell function in individuals newly diagnosed with Type 1 diabetes. The investigators hypothesize that probiotic-induced alterations in the intestinal microbiota may favorably alter the post-onset disease state.
Read the detailed description
For individuals newly diagnosed with Type 1 diabetes, this clinical trial will assess whether probiotic supplementation has efficacy in reducing the endogenous systemic innate inflammatory state known to exist in newly diagnosed Type 1 diabetes and whether this reduction correlates with preservation of endogenous insulin production as measured by stimulated C-peptide during mixed meal tolerance testing (MMTT). The innate inflammatory state will be measured by plasma-induced transcriptional assay and quantified as a composite inflammatory index. Mixed meal tolerance testing is the gold standard measure of endogenous insulin production. During this test, serial blood c-peptide levels are collected over 2 hours in response to challenge with a nutritional drink containing a mix of protein, fat, and carbohydrate and the C-peptide area under the curve is calculated.
Using a randomized, placebo-controlled design, the investigators will measure changes in systemic inflammation (primary outcome) and beta cell function (secondary outcome) after six months of daily treatment with either Lp299v supplementation or placebo. These measures of plasma-induced transcriptional assay and MMTT will be related to markers of beta cell stress, the composition of the gut microbiota, analysis of the plasma metabolome, and levels of microbial antigen exposure.
- Conditions
- Type 1 Diabetes, type1diabetes, Type 1 Diabetes Mellitus
- Being tested
- Lactiplantibacillus plantarum, Placebo
- Keywords
- New onset, Newly diagnosed, Recent onset, Probiotic, Lactiplantibacillus plantarum, Lp299v
- 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.
Lactiplantibacillus plantarumDietary supplement
Also called Lp299v
Probiotic capsule in powder form, which can be swallowed or opened and contents sprinkled on cold foods or beverages
PlaceboOther
Placebo capsule in powder form, which can be swallowed or opened and contents sprinkled on cold foods or beverages
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Subjects will be randomized to the treatment or placebo group. The treatment is a capsule taken by mouth once a day for 6 months. Receives: Dietary Supplement: Lactiplantibacillus plantarum |
| Placebo Group | Placebo comparator | Subjects will be randomized to the treatment or placebo group. The placebo is a capsule taken by mouth once a day for 6 months. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in composite inflammatory index after probiotic supplementation
Investigators will examine the effect of probiotic supplementation on the endogenous innate inflammatory state in youth newly diagnosed with T1D, as measured by plasma-induced transcription and analyzed using a composite inflammatory index score. The investigators hypothesize that the subjects receiving the probiotic will have less inflammation (as measured by transcriptional analysis) than the participants in the placebo group.
Measured: 5 years (duration of study)
Secondary outcomes (7)
Rate of stimulated C-peptide Area Under the Curve (AUC) decline after probiotic supplementation
Investigators will examine the rate of C-peptide decline, as measured by C-peptide AUC in youth newly diagnosed with T1D. The investigators hypothesize that the subjects receiving the probiotic for 6 months will have a slower rate of decline than the subjects in the placebo group.
Measured: 5 years (duration of study)
Markers of beta cell function
Investigators will examine the effect of probiotic supplementation on beta cell function by measuring proinsulin levels, ratio of proinsulin to C-peptide and islet amyloid polypeptide to pro-islet amyloid polypeptide ratio.
Measured: 5 years (duration of study)
Microbial composition as measured by 16s rRNA sequencing
Investigators will examine the effect of probiotic supplementation using 16s rRNA sequencing to determine the composition of the intestinal microbiota. Investigators hypothesize the composition of the intestinal microbiota will differ before and after treatment with probiotic supplementation.
Measured: 5 years (duration of study)
Markers of systemic microbial antigen exposure
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: 5 years (duration of study)
Regulatory T cell abundance and activity by flow cytometry
Investigators will examine the effect of probiotic supplementation on regulatory T cell abundance and activity.
Measured: 5 years (duration of study)
Monocyte abundance and activity by flow cytometry
Investigators will examine the effect of probiotic supplementation on monocyte abundance and activity.
Measured: 5 years (duration of study)
scRNA-seq analyses of peripheral blood mononuclear cells
Investigators will examine the effect of probiotic supplementation on peripheral blood mononuclear cells using single cell RNA sequencing analysis.
Measured: 5 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 posted6 Apr 2020
- Study start1 Apr 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 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.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, placebo-controlled, 2:1 randomly assigned
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 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
- NCT04335656
- Sponsor's protocol ID
- 1560525
- Status last verified
- Oct 2026
- First submitted
- 27 Mar 2020
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Innate Inflammation in New Onset Type 1 Diabetes With Lactiplantibacillus Plantarum
- ClinicalTrials.gov ID
- NCT04335656
- Acronym / sponsor ID
- 1560525
- Conditions
- Type 1 Diabetes, type1diabetes, Type 1 Diabetes Mellitus
- Keywords
- New onset, Newly diagnosed, Recent onset, Probiotic, Lactiplantibacillus plantarum, Lp299v
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Apr 2020 (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.
This study aims to determine whether Lactiplantibacillus plantarum 299v (Lp299v) supplementation will reduce systemic inflammation and prolong residual beta cell function in individuals newly diagnosed with Type 1 diabetes. The investigators hypothesize that probiotic-induced alterations in the intestinal microbiota may favorably alter the post-onset disease state.
Detailed description
For individuals newly diagnosed with Type 1 diabetes, this clinical trial will assess whether probiotic supplementation has efficacy in reducing the endogenous systemic innate inflammatory state known to exist in newly diagnosed Type 1 diabetes and whether this reduction correlates with preservation of endogenous insulin production as measured by stimulated C-peptide during mixed meal tolerance testing (MMTT). The innate inflammatory state will be measured by plasma-induced transcriptional assay and quantified as a composite inflammatory index. Mixed meal tolerance testing is the gold standard measure of endogenous insulin production. During this test, serial blood c-peptide levels are collected over 2 hours in response to challenge with a nutritional drink containing a mix of protein, fat, and carbohydrate and the C-peptide area under the curve is calculated.
Using a randomized, placebo-controlled design, the investigators will measure changes in systemic inflammation (primary outcome) and beta cell function (secondary outcome) after six months of daily treatment with either Lp299v supplementation or placebo. These measures of plasma-induced transcriptional assay and MMTT will be related to markers of beta cell stress, the composition of the gut microbiota, analysis of the plasma metabolome, and levels of microbial antigen exposure.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, placebo-controlled, 2:1 randomly assigned
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Dietary Supplement: Lactiplantibacillus plantarumSubjects will be randomized to the treatment or placebo group. The treatment is a capsule taken by mouth once a day for 6 months. |
| Placebo Group | Placebo comparator | Other: PlaceboSubjects will be randomized to the treatment or placebo group. The placebo is a capsule taken by mouth once a day for 6 months. |
Who may qualify
- Ages
- 3 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- ≤ 100 days from T1D diagnosis based on ADA criteria
- > 21 days from T1D diagnosis or metabolically stable per study physician assessment
- Males and females 3-45 years of age, inclusive, at time of screening visit
- Peak MMTT stimulated C-peptide ≥ 0.2 nmol/L
- Positive for at least 1 diabetes autoantibody (excluding mIAA in those who have received ≥ 2 weeks of exogenous insulin therapy) either through clinically obtained labs at time of diagnosis or as obtained at the screening visit
Key exclusion criteria (10 listed)
- Probiotic supplement use within the past month
- Antibiotic use within the past month
- Concurrent or recent (within the past 30 days of screening) use of non-insulin therapies aimed to control hyperglycemia
- Females who are pregnant or lactating
- Chronic inflammatory or autoimmune disease with exception of stable thyroid disease
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 |
|---|---|---|
| Lactiplantibacillus plantarumAlso: Lp299vProbiotic capsule in powder form, which can be swallowed or opened and contents sprinkled on cold foods or beverages | Dietary supplement | Treatment Group |
| PlaceboPlacebo capsule in powder form, which can be swallowed or opened and contents sprinkled on cold foods or beverages | Other | Placebo Group |
Primary outcome
Change in composite inflammatory index after probiotic supplementation
Time frame: 5 years (duration of study)
Investigators will examine the effect of probiotic supplementation on the endogenous innate inflammatory state in youth newly diagnosed with T1D, as measured by plasma-induced transcription and analyzed using a composite inflammatory index score. The investigators hypothesize that the subjects receiving the probiotic will have less inflammation (as measured by transcriptional analysis) than the participants in the placebo group.
7 secondary outcomes
Rate of stimulated C-peptide Area Under the Curve (AUC) decline after probiotic supplementation
Time frame: 5 years (duration of study)
Markers of beta cell function
Time frame: 5 years (duration of study)
Microbial composition as measured by 16s rRNA sequencing
Time frame: 5 years (duration of study)
Markers of systemic microbial antigen exposure
Time frame: 5 years (duration of study)
Regulatory T cell abundance and activity by flow cytometry
Time frame: 5 years (duration of study)
Monocyte abundance and activity by flow cytometry
Time frame: 5 years (duration of study)
scRNA-seq analyses of peripheral blood mononuclear cells
Time frame: 5 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 20 Oct 2026.
- 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 Lactiplantibacillus plantarum 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 7 inclusion and 10 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 20 Oct 2026. 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?
Change in composite inflammatory index after probiotic supplementation (time frame: 5 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 20 Oct 2026.