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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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

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

Other trials in United States

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 groups in NCT04335656
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.

1 Apr 202131 Dec 2027

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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