Reducing Innate Inflammation in New Onset Type 1 Diabetes

NCT04335656 | Active Not Recruiting Phase 2

• 1 other identifier: 1560525
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

New onset; Newly diagnosed; Recent onset; Probiotic; Lactiplantibacillus plantarum; Lp299v

Outcome Measures

Primary Outcomes (1)

• 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.

  5 years (duration of study)

Secondary Outcomes (7)

• Rate of stimulated C-peptide Area Under the Curve (AUC) decline after probiotic supplementation

  5 years (duration of study)

• Markers of beta cell function

  5 years (duration of study)

• Microbial composition as measured by 16s rRNA sequencing

  5 years (duration of study)

• Markers of systemic microbial antigen exposure

  5 years (duration of study)

• Regulatory T cell abundance and activity by flow cytometry

  5 years (duration of study)

Study Arms (2)

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.

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.

Other: Placebo

Interventions

Placebo OTHER

Placebo capsule in powder form, which can be swallowed or opened and contents sprinkled on cold foods or beverages

Placebo Group

Lactiplantibacillus plantarum DIETARY_SUPPLEMENT

Probiotic capsule in powder form, which can be swallowed or opened and contents sprinkled on cold foods or beverages

Also known as: Lp299v

Treatment Group

Eligibility Criteria

• Age: 3 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ≤ 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

You may not qualify if:

• 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.)
• 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.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Double-blind, placebo-controlled, 2:1 randomly assigned

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: April 6, 2020
• Study Start: April 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)